FDA releases May 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2016
TOTAL 510(k)s THIS PERIOD 213
TOTAL WITH SUMMARIES 205
TOTAL WITH STATEMENTS 8
May 2016 510(k) Clearances
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510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2016
DEVICE: O-PEP
PARI RESPIRATORY EQUIPMENT, INC. 510(k) NO: K150044(Traditional)
ATTN: Michael Judge PHONE NO : 1 804 2537274
2412 PARI Way SE DECISION MADE: 27-MAY-16
Midlothian VA 23112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERBE ESU Model VIO dV with Accessories
ERBE ELEKTROMEDIZIN GMBH 510(k) NO: K150364(Traditional)
ATTN: Axel Retzlaff PHONE NO : 49 7071 70755349
WALDHOERNLESTRASSE, 17 SE DECISION MADE: 05-MAY-16
TUEBINGEN DE 72072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Filbloc
ASSUT EUROPE 510(k) NO: K150553(Traditional)
ATTN: GLORIA AGGIO PHONE NO : 39 06 72677348
ZONA INDUSTRIALE SE DECISION MADE: 19-MAY-16
MAGLIANO DEI MARSI IT 1-67062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINPOINT Endoscopic Fluorescence Imaging System
NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K15095...
Source: Mass Device - Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
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