The following data is part of a premarket notification filed by Prism Technologies, Inc. with the FDA for Instant Warm Gel Pack.
| Device ID | K912715 |
| 510k Number | K912715 |
| Device Name: | INSTANT WARM GEL PACK |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | PRISM TECHNOLOGIES, INC. 3111 NORTH KNOX AVE. Chicago, IL 60641 |
| Contact | Charles F Manker |
| Correspondent | Charles F Manker PRISM TECHNOLOGIES, INC. 3111 NORTH KNOX AVE. Chicago, IL 60641 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-18 |
| Decision Date | 1991-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937025730 | K912715 | 000 |
| 20888937025723 | K912715 | 000 |
| 30888937020145 | K912715 | 000 |
| 30888937020015 | K912715 | 000 |