The following data is part of a premarket notification filed by Prism Technologies, Inc. with the FDA for Coldgel.
| Device ID | K953542 |
| 510k Number | K953542 |
| Device Name: | COLDGEL |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | PRISM TECHNOLOGIES, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Howard M Holsetin |
| Correspondent | Howard M Holsetin PRISM TECHNOLOGIES, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-28 |
| Decision Date | 1995-10-30 |