The following data is part of a premarket notification filed by Geiger Medical Technologies, Inc. with the FDA for Blue Value Line Of Electrosurgical Electrodes, Model #'s 421-429.
| Device ID | K983852 |
| 510k Number | K983852 |
| Device Name: | BLUE VALUE LINE OF ELECTROSURGICAL ELECTRODES, MODEL #'S 421-429 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GEIGER MEDICAL TECHNOLOGIES, INC. 24040 CAMINO DEL AVION, A-195 Monarch Beach, CA 92629 |
| Contact | John Bottjer |
| Correspondent | John Bottjer GEIGER MEDICAL TECHNOLOGIES, INC. 24040 CAMINO DEL AVION, A-195 Monarch Beach, CA 92629 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-30 |
| Decision Date | 1999-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00609960000398 | K983852 | 000 |
| 00609960000336 | K983852 | 000 |
| 00609960001289 | K983852 | 000 |