INFLATABLE RETENTION CUFF SPECULUM— 510(k) K941391

Name: FDA 510(k) clearance K941391
Creator: U.S. Food and Drug Administration
Published: 1994-10-20

Substantially Equivalent

Innovatec Medical Corp.

FDA 510(k) clearance K941391 for INFLATABLE RETENTION CUFF SPECULUM, Substantially Equivalent on 1994-10-20. Applicant: Innovatec Medical Corp.. Device class: 2.

Clearance details

Applicant: Innovatec Medical Corp.
Product code: Code GBT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1994-03-22
Decision date: 1994-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Duluth, GA, US

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