The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Polygel Ultrasound Gel.
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10303410000026 | K851895 | 000 |