The following data is part of a premarket notification filed by Mckinley-ross Laboratories, Inc. with the FDA for Hemo-stat.
| Device ID | K922636 |
| 510k Number | K922636 |
| Device Name: | HEMO-STAT |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | MCKINLEY-ROSS LABORATORIES, INC. 127 TOMAHAWK INDUSTRIAL PARK Lynchburg, VA 24502 |
| Contact | Millard Minton |
| Correspondent | Millard Minton MCKINLEY-ROSS LABORATORIES, INC. 127 TOMAHAWK INDUSTRIAL PARK Lynchburg, VA 24502 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-29 |
| Decision Date | 1992-11-09 |