Atlas FDA

FZI

5 FDA 510(k) clearances · Product code

53 daysmedian time to decision
72 days90th percentile
5clearances measured

FDA profile

Official device name
Apparatus, Air Handling, Enclosure
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5070
Medical specialty
General, Plastic Surgery
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RecordFirmDate
MULTIPLE, SURGICAL DRAPE PACK (K911132)Central Georgia Ancillary Health Systems1991-05-06
STERILE DISPOSABLE DRAPE(S) (K910468)E.M. Adams1991-03-21
ELLIPTI-PUNCH (K854159)Alcon Laboratories1985-11-15
DAVIS RHYTIDECTOMY (K772395)Edward Weck, Inc.1978-03-09
KALRN FACE-LIFE SCISSORS (K772394)Edward Weck, Inc.1978-03-09

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Every clearance here is in the API, with alerts when new ones post.