The following data is part of a premarket notification filed by Mahe-medizintechnik with the FDA for Punch Surgical.
Device ID | K933772 |
510k Number | K933772 |
Device Name: | PUNCH SURGICAL |
Classification | Orthopedic Manual Surgical Instrument |
Applicant | MAHE-MEDIZINTECHNIK 300 JAMES ROBERTSON PKWY. Nashville, TN 37201 |
Contact | Winfried Reich |
Correspondent | Winfried Reich MAHE-MEDIZINTECHNIK 300 JAMES ROBERTSON PKWY. Nashville, TN 37201 |
Product Code | LXH |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-29 |
Decision Date | 1994-02-01 |