The following data is part of a premarket notification filed by Geiger Medical Technologies, Inc. with the FDA for Geiger Needle Adapter, Model 406.
| Device ID | K001029 |
| 510k Number | K001029 |
| Device Name: | GEIGER NEEDLE ADAPTER, MODEL 406 |
| 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 | 2000-03-30 |
| Decision Date | 2000-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00609960001272 | K001029 | 000 |
| 00609960000305 | K001029 | 000 |