DRAPE, SURGICAL-LATEX— 510(k) K970891

Name: FDA 510(k) clearance K970891
Creator: U.S. Food and Drug Administration
Published: 1997-08-22

Substantially Equivalent

Protek Medical Products, Inc.

FDA 510(k) clearance K970891 for DRAPE, SURGICAL-LATEX, Substantially Equivalent on 1997-08-22. Applicant: Protek Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Protek Medical Products, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1997-03-11
Decision date: 1997-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Iowa City, IA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Protek Medical Products, Inc.

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K973958 — GENERAL PURPOSE ATL NEEDLE GUIDE KIT1998-01-22
K973622 — TRANSDUCER POSITIONER1997-11-26
K970889 — ULTRASOUND TRANSDUCER DRAPE1997-10-20
K970893 — ULTRASOUND TRANSDUCER DRAPE1997-10-20
K973362 — NEEDLE GUIDE/GRID1997-10-01

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