FDA releases June 2016 510(k) clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD June 2016

TOTAL 510(k)s THIS PERIOD 258
TOTAL WITH SUMMARIES 235
TOTAL WITH STATEMENTS 23

DEVICE: ORAL BOND
STEINER LABORATORIES 510(k) NO: K142130(Traditional)
ATTN: GREGORY G STEINER PHONE NO : 866 3171348
1051 Olsen Street, Building 3611 SE DECISION MADE: 06-JUN-16
Henderson NV 89011 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QiF Blood and Fluid Warmer
Quality in Flow Ltd. 510(k) NO: K150404(Traditional)
ATTN: Neta Sherman PHONE NO : 972 54 6600146
3A Bazel St. POB 10159 SE DECISION MADE: 23-JUN-16
Petach Tikva IL 49002 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X-VIEW, IMAGEN
EDLEN IMAGING LLC 510(k) NO: K151137(Abbreviated)
ATTN: NICK RADACHI PHONE NO : 480 6598430
16441 NORTH 91ST STREET SUITE 102 SE DECISION MADE: 07-JUN-16
SCOTTSDALE AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABC D-FLEX PROBE
CONMED CORPORATION 510(k) NO: K151229(Traditional)
ATTN: SANDY LECLAIR PHONE NO : 1 315 6243435
525 FRENCH ROAD SE DECISION MADE: 02-JUN-16
UTICA NY 11502 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI DUAL PORT II
NAVILYST MEDICAL, INC. 510(k) NO: K151239(Traditional)
ATTN: ROBIN FULLER PHONE NO : 508 6587986
26 FOREST STREET ...

Source: Mass Device - August 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news