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Abdovac (Tm), Bellovac (Tm) and Exudrain

by Astra Meditec AB 510(k)

Active United States

510(k) K920819

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK920819 Date24 Mar 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GCY
Device Class
Class I
Regulation
21 CFR Part 878.4680
Advisory Committee
General, Plastic Surgery
FDA Decision
SESK Substantially Equivalent — Kit

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