GAUZE SPONGE; DRAIN SPONGE— 510(k) K935940

Name: FDA 510(k) clearance K935940
Creator: U.S. Food and Drug Administration
Published: 1994-01-14

Substantially Equivalent

Mcneil Healthcare, Inc.

FDA 510(k) clearance K935940 for GAUZE SPONGE; DRAIN SPONGE, Substantially Equivalent on 1994-01-14. Applicant: Mcneil Healthcare, Inc.. Device class: Unclassified.

Clearance details

Applicant: Mcneil Healthcare, Inc.
Product code: Code EFQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1993-12-13
Decision date: 1994-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waterford, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFQ

view all

K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE1999-08-12
K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S1999-06-11
K990974 — VITOP DRESSING1999-06-09
K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE1999-04-23
K984187 — CROSSTEX NON-WOVEN SPONGES1999-02-18

More clearances from Mcneil Healthcare, Inc.

view all

K935883 — NEUROLOGICAL SPONGES1994-02-03
K935930 — NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING1994-02-03
K935993 — SURGICAL SPONGE X-RAY DETECTABLE1994-02-02
K935881 — SPECIALTY SPONGES1994-01-31
K935882 — TONSIL SPONGES1994-01-31

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