The following data is part of a premarket notification filed by Garan Scientific, Inc. with the FDA for The Heart Protector.
| Device ID | K944481 |
| 510k Number | K944481 |
| Device Name: | THE HEART PROTECTOR |
| Classification | Dispenser, Solid Medication |
| Applicant | GARAN SCIENTIFIC, INC. P.O. BOX 1396 Morristown, NJ 07960 |
| Contact | Gary Stern |
| Correspondent | Gary Stern GARAN SCIENTIFIC, INC. P.O. BOX 1396 Morristown, NJ 07960 |
| Product Code | NXB |
| CFR Regulation Number | 890.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-13 |
| Decision Date | 1995-04-10 |
| Summary: | summary |