STERILE DISPOSABLE DRAPE(S)— 510(k) K910468

Substantially Equivalent

E.M. Adams

FDA 510(k) clearance K910468 for STERILE DISPOSABLE DRAPE(S), Substantially Equivalent on 1991-03-21. Applicant: E.M. Adams. Device class: 2.

Clearance details

Applicant: E.M. Adams
Product code: Code FZI
Device class: Class 2
Regulation: 21 CFR 878.5070
Advisory panel: General, Plastic Surgery
Date received: 1991-02-04
Decision date: 1991-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

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Recent devices under product code FZI

K911132 — MULTIPLE, SURGICAL DRAPE PACK1991-05-06
K854159 — ELLIPTI-PUNCH1985-11-15
K772394 — KALRN FACE-LIFE SCISSORS1978-03-09
K772395 — DAVIS RHYTIDECTOMY1978-03-09

More clearances from E.M. Adams

K905173 — SPLASH GUARD1991-04-25
K873978 — DISPOSABLE BIPOLAR FORCEPS1987-11-23
K850063 — INSTRUMENT POCKET1985-02-21
K843724 — I.V. START KIT & OBSTETRICAL KIT1985-01-10
K843783 — WET PACK1984-12-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.