ULTRASOUND TRANSDUCER DRAPE

Gown, 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: K970893
• 510k Number: K970893
• Device Name: ULTRASOUND TRANSDUCER DRAPE
• Classification: Gown, 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: FYA
• CFR Regulation Number: 878.4040 [🔎]
• 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
10841912100399	K970893	000
10841912100207	K970893	000
00841912100194	K970893	000
00841912100187	K970893	000
10841912100177	K970893	000
00841912100163	K970893	000
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00841912100149	K970893	000
00841912100125	K970893	000
00841912100118	K970893	000
00841912100071	K970893	000
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10841912100214	K970893	000
10841912100221	K970893	000
10841912100238	K970893	000
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10841912100375	K970893	000
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00841912100316	K970893	000
00841912100309	K970893	000
00841912100293	K970893	000
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10841912100245	K970893	000
00841912100057	K970893	000
00841912100040	K970893	000
10841912106919	K970893	000
10841912106902	K970893	000
10841912106896	K970893	000
10841912106889	K970893	000
10841912106230	K970893	000
00841912103317	K970893	000
10841912107053	K970893	000
10841912107084	K970893	000
50850025153176	K970893	000
50850025153169	K970893	000
50850025153152	K970893	000
10841912105509	K970893	000
10841912106315	K970893	000
10841912106735	K970893	000
00841912100033	K970893	000
10841912100023	K970893	000
30841912103318	K970893	000
20841912103311	K970893	000
00841912106394	K970893	000
00841912106356	K970893	000
00841912106332	K970893	000
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10841912104496	K970893	000
10841912105172	K970893	000
10841912105196	K970893	000
10841912105219	K970893	000
10841912105844	K970893	000
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