The following data is part of a premarket notification filed by Florida Medical Industries, Inc. with the FDA for Recover Infant Heel Warmer (5100).
| Device ID | K964523 |
| 510k Number | K964523 |
| Device Name: | RECOVER INFANT HEEL WARMER (5100) |
| Classification | Infant Heel Warmer (chemical Heat Pack) |
| 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 | MPO |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-12 |
| Decision Date | 1997-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884527004635 | K964523 | 000 |
| 20884527004628 | K964523 | 000 |