The following data is part of a premarket notification filed by Mahe-medizintechnik with the FDA for Forceps, Ent Instr, Ent Manual Surg Retract/all Type.
Device ID | K933770 |
510k Number | K933770 |
Device Name: | FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE |
Classification | Instrument, Ent Manual Surgical |
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 | LRC |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-29 |
Decision Date | 1994-03-23 |