The following data is part of a premarket notification filed by Mahe-medizintechnik with the FDA for Microsurgical Instruments.
Device ID | K925624 |
510k Number | K925624 |
Device Name: | MICROSURGICAL INSTRUMENTS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | MAHE-MEDIZINTECHNIK FOEHRENSTR 45 7200 TUTTLINGEN Germany, DE |
Contact | Theo Heckmann |
Correspondent | Theo Heckmann MAHE-MEDIZINTECHNIK FOEHRENSTR 45 7200 TUTTLINGEN Germany, DE |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-06 |
Decision Date | 1993-07-22 |