The following data is part of a premarket notification filed by Adler Micromed Inc. with the FDA for Adler Micromed Laser Surgery Fibers.
| Device ID | K152417 |
| 510k Number | K152417 |
| Device Name: | Adler MicroMed Laser Surgery Fibers |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ADLER MICROMED INC. 6842 ELAINE WAY San Diego, CA 92120 |
| Contact | Brian Chandler |
| Correspondent | Brian Chandler ADLER MICROMED INC. 6842 ELAINE WAY San Diego, CA 92120 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-26 |
| Decision Date | 2015-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850348007304 | K152417 | 000 |
| 00850348007441 | K152417 | 000 |
| 00850348007472 | K152417 | 000 |
| 00850348007502 | K152417 | 000 |
| 00850348007533 | K152417 | 000 |
| 00850348007380 | K152417 | 000 |
| 00850348007007 | K152417 | 000 |
| 00850348007014 | K152417 | 000 |
| 00850348007021 | K152417 | 000 |
| 00850348007038 | K152417 | 000 |
| 00850348007052 | K152417 | 000 |
| 00850348007205 | K152417 | 000 |
| 00850348007236 | K152417 | 000 |
| 00850348007267 | K152417 | 000 |
| 00850348007274 | K152417 | 000 |
| 00850348007410 | K152417 | 000 |