The following data is part of a premarket notification filed by Tempo Technology, Inc. with the FDA for Tempra Cold Pack, Reorder No. Tc150.
| Device ID | K963220 |
| 510k Number | K963220 |
| Device Name: | TEMPRA COLD PACK, REORDER NO. TC150 |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | TEMPO TECHNOLOGY, INC. 5945 NORTH WASHINGTON BLVD. Sarasota, FL 34243 |
| Contact | Jay Ruehlen |
| Correspondent | Jay Ruehlen TEMPO TECHNOLOGY, INC. 5945 NORTH WASHINGTON BLVD. Sarasota, FL 34243 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-16 |
| Decision Date | 1996-10-10 |