The following data is part of a premarket notification filed by Aslan Medical Technologies, Ltd. with the FDA for Mckernan-adson Aggressive Forceps.
Device ID | K926281 |
510k Number | K926281 |
Device Name: | MCKERNAN-ADSON AGGRESSIVE FORCEPS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ASLAN MEDICAL TECHNOLOGIES, LTD. 6376 QUAIL RUN DR. Kalamazoo, MI 49009 |
Contact | Thomas J Hoogeboom |
Correspondent | Thomas J Hoogeboom ASLAN MEDICAL TECHNOLOGIES, LTD. 6376 QUAIL RUN DR. Kalamazoo, MI 49009 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-14 |
Decision Date | 1993-03-09 |