ULTRASOUND TRANSDUCER DRAPE

Drape, Surgical

PROTEK MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Protek Medical Products, Inc. with the FDA for Ultrasound Transducer Drape.

Pre-market Notification Details

• Device ID: K970889
• 510k Number: K970889
• Device Name: ULTRASOUND TRANSDUCER DRAPE
• Classification: Drape, Surgical
• Applicant: PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245
• Contact: Rick L Pruter
• Correspondent: Rick L Pruter; PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245
• Product Code: KKX
• CFR Regulation Number: 878.4370 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-03-11
• Decision Date: 1997-10-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10841912107091	K970889	000
00841912100101	K970889	000
00841912100132	K970889	000
00841912100262	K970889	000
00841912100286	K970889	000
10841912100481	K970889	000
00841912100491	K970889	000
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00841912100514	K970889	000
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10841912100535	K970889	000
10841912100542	K970889	000
10841912100566	K970889	000
10841912100573	K970889	000
10841912100580	K970889	000
10841912100597	K970889	000
10841912100603	K970889	000
10841912100610	K970889	000
00841912100095	K970889	000
00841912100088	K970889	000
10841912100016	K970889	000
20841912104714	K970889	000
10841912106971	K970889	000
20809160355630	K970889	000
10841912106964	K970889	000
10841912106957	K970889	000
10841912106872	K970889	000
10841912106537	K970889	000
10841912106193	K970889	000
80841912104266	K970889	000
10841912106254	K970889	000
10841912106278	K970889	000
10841912106421	K970889	000
10841912106414	K970889	000
00841912105885	K970889	000
60841912104262	K970889	000
20841912102888	K970889	000
40841912104268	K970889	000
10841912100627	K970889	000
10841912100634	K970889	000
10841912100696	K970889	000
10841912101426	K970889	000
10841912101457	K970889	000
10841912104021	K970889	000
10841912104038	K970889	000
10841912104045	K970889	000
10841912104359	K970889	000
10841912104366	K970889	000
00841912104574	K970889	000
10841912104755	K970889	000
10841912105233	K970889	000
10841912105431	K970889	000
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10841912105813	K970889	000
10841912105820	K970889	000
10841912101419	K970889	000
10841912101402	K970889	000
10841912101396	K970889	000
10841912100702	K970889	000
10841912100719	K970889	000
10841912100726	K970889	000
10841912100733	K970889	000
10841912100740	K970889	000
10841912100757	K970889	000
10841912100764	K970889	000
10841912100771	K970889	000
10841912100788	K970889	000
10841912100795	K970889	000
10841912100801	K970889	000
10841912100818	K970889	000
10841912100825	K970889	000
10841912100832	K970889	000
10841912100849	K970889	000
10841912100856	K970889	000
10841912101143	K970889	000
00841912105663	K970889	000