The following data is part of a premarket notification filed by Aaron Medical, Inc. with the FDA for Handpiece Sheath-model #a910.
| Device ID | K011929 |
| 510k Number | K011929 |
| Device Name: | HANDPIECE SHEATH-MODEL #A910 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AARON MEDICAL, INC. 7100- 30TH AVENUE NORTH St. Petersburg, FL 33710 |
| Contact | Richard Kozloff |
| Correspondent | Richard Kozloff AARON MEDICAL, INC. 7100- 30TH AVENUE NORTH St. Petersburg, FL 33710 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-20 |
| Decision Date | 2001-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887482032725 | K011929 | 000 |