The following data is part of a premarket notification filed by Florida Medical Industries, Inc. with the FDA for Recover Adult Vein Warmer.
| Device ID | K963689 |
| 510k Number | K963689 |
| Device Name: | RECOVER ADULT VEIN WARMER |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | FLORIDA MEDICAL INDUSTRIES, INC. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb FLORIDA MEDICAL INDUSTRIES, INC. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1996-12-12 |
| Summary: | summary |