ULTRACELL SUCTION SPONGE— 510(k) K972633

Name: FDA 510(k) clearance K972633
Creator: U.S. Food and Drug Administration
Published: 1997-12-17

Substantially Equivalent

Ultracell Medical Technologies, Inc.

FDA 510(k) clearance K972633 for ULTRACELL SUCTION SPONGE, Substantially Equivalent on 1997-12-17. Applicant: Ultracell Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Ultracell Medical Technologies, Inc.
Product code: Code HOZ
Device class: Class 2
Regulation: 21 CFR 886.4790
Advisory panel: Ophthalmic
Date received: 1997-07-14
Decision date: 1997-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Stonington, CT, US

Download summary PDF View on FDA.gov ↗

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K973558 — VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)1997-11-24
K973085 — ULTRACELL PACKING WITH SLEEVE1997-11-18
K972635 — ULTRACELL SUCTION SPONGE1997-10-01

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