The following data is part of a premarket notification filed by Aslan Medical Technologies, Ltd. with the FDA for Mckernan Atraumatic Forceps.
| Device ID | K925041 |
| 510k Number | K925041 |
| Device Name: | MCKERNAN ATRAUMATIC FORCEPS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ASLAN MEDICAL TECHNOLOGIES, LTD. 100 HEGENBERGER RD. SUITE 210 Oakland, CA 94621 |
| Contact | Douglas Donaldson |
| Correspondent | Douglas Donaldson ASLAN MEDICAL TECHNOLOGIES, LTD. 100 HEGENBERGER RD. SUITE 210 Oakland, CA 94621 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-05 |
| Decision Date | 1992-11-25 |