The following data is part of a premarket notification filed by Geiger Instrument Co., Inc. with the FDA for Aaron 800 High Frequency Desiccator/handpiece.
Device ID | K955681 |
510k Number | K955681 |
Device Name: | AARON 800 HIGH FREQUENCY DESICCATOR/HANDPIECE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | GEIGER INSTRUMENT CO., INC. 24040 CAMINO DEL AVION, A-195 Monarch Beach, CA 92629 |
Contact | John Bottjer |
Correspondent | John Bottjer GEIGER INSTRUMENT CO., 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 | 1995-12-14 |
Decision Date | 1996-02-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00607151018016 | K955681 | 000 |
00607151001438 | K955681 | 000 |