The following data is part of a premarket notification filed by E.m. Adams with the FDA for Disposable Bipolar Forceps.
Device ID | K873978 |
510k Number | K873978 |
Device Name: | DISPOSABLE BIPOLAR FORCEPS |
Classification | Forceps, General & Plastic Surgery |
Applicant | E.M. ADAMS 121 WEST ST. Medfield, MA 02052 |
Contact | Richard K Donahue |
Correspondent | Richard K Donahue E.M. ADAMS 121 WEST ST. Medfield, MA 02052 |
Product Code | GEN |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-30 |
Decision Date | 1987-11-23 |