The following data is part of a premarket notification filed by Byron Medical with the FDA for Biopsy Punch, Surgical.
Device ID | K933670 |
510k Number | K933670 |
Device Name: | BIOPSY PUNCH, SURGICAL |
Classification | Punch, Biopsy, Surgical |
Applicant | BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
Contact | Byron G Economidy, Jr. |
Correspondent | Byron G Economidy, Jr. BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
Product Code | EME |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-28 |
Decision Date | 1994-01-07 |