The following data is part of a premarket notification filed by Mahe-medizintechnik with the FDA for Forceps, Biopsy Gynecological Instru/biopsy.
Device ID | K933767 |
510k Number | K933767 |
Device Name: | FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY |
Classification | Forceps, Biopsy, Gynecological |
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 | HFB |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-29 |
Decision Date | 1994-05-26 |