POLYGEL ULTRASOUND GEL

System, Imaging, Pulsed Echo, Ultrasonic

PARKER LABORATORIES, INC.

The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Polygel Ultrasound Gel.

Pre-market Notification Details

• Device ID: K851895
• 510k Number: K851895
• Device Name: POLYGEL ULTRASOUND GEL
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: PARKER LABORATORIES, INC. 307 WASHINGTON ST. Orange, NJ 07050
• Contact: Martin Buchalter
• Correspondent: Martin Buchalter; PARKER LABORATORIES, INC. 307 WASHINGTON ST. Orange, NJ 07050
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-04-30
• Decision Date: 1985-09-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10303410000026	K851895	000
10303410000033	K851895	000
10303410000019	K851895	000