The following data is part of a premarket notification filed by Black & Black Surgical, Inc. with the FDA for Black And Black Electrosurgical Cutting And Coagulation Forceps And Electrodes.
| Device ID | K072124 |
| 510k Number | K072124 |
| Device Name: | BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BLACK & BLACK SURGICAL, INC. 2759 HAWTHORNE DR. Atlanta, GA 30345 |
| Contact | Norman M Black, Iii |
| Correspondent | Norman M Black, Iii BLACK & BLACK SURGICAL, INC. 2759 HAWTHORNE DR. Atlanta, GA 30345 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-02 |
| Decision Date | 2008-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B089B688100 | K072124 | 000 |
| B089B680100 | K072124 | 000 |
| B089B680050 | K072124 | 000 |
| B089B680000 | K072124 | 000 |
| B089B653000 | K072124 | 000 |
| B089B652450 | K072124 | 000 |
| B089B652440 | K072124 | 000 |
| B089B652430 | K072124 | 000 |
| B089B652420 | K072124 | 000 |
| B089B652400 | K072124 | 000 |
| B089B652280 | K072124 | 000 |
| B089B680150 | K072124 | 000 |
| B089B680160 | K072124 | 000 |
| B089B681300 | K072124 | 000 |
| B089B681200 | K072124 | 000 |
| B089B681150 | K072124 | 000 |
| B089B681100 | K072124 | 000 |
| B089B681050 | K072124 | 000 |
| B089B681000 | K072124 | 000 |
| B089B680350 | K072124 | 000 |
| B089B680300 | K072124 | 000 |
| B089B680250 | K072124 | 000 |
| B089B680200 | K072124 | 000 |
| B089B652270 | K072124 | 000 |