The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Poly-medics Heat Pack.
| Device ID | K941245 |
| 510k Number | K941245 |
| Device Name: | POLY-MEDICS HEAT PACK |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary Verstynen |
| Correspondent | Mary Verstynen BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-15 |
| Decision Date | 1994-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036077969 | K941245 | 000 |
| 00841036054229 | K941245 | 000 |