Atlas FDA

ALGINATE FIBER

FDA 510(k) clearance K914779 · decided 1991-12-04

Clearance details

K-number
K914779
Device name
ALGINATE FIBER
Applicant
Adri/Technam
Decision
Substantially Equivalent
Date received
1991-10-23
Decision date
1991-12-04
Days to decision
42 days
Clearance type
Traditional
Product code
NAC
Device class
1
Regulation number
878.4018
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Park Forest, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Adri/Technam

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER (K082208)Scivolutions, Inc.2008-12-01
HYDRASORB JOYCE SPONGE (K925841)Avitar, Inc.1993-05-12
SORBSAN TOPICAL WOUND DRESSING (MODIFIED) (K914575)Dow B. Hickam, Inc.1991-12-04

Recalls involving this device

No recalls on record reference this clearance.