The following data is part of a premarket notification filed by Tti Medical with the FDA for Accu-beam Fiber Optic Handpiece.
| Device ID | K952006 |
| 510k Number | K952006 |
| Device Name: | ACCU-BEAM FIBER OPTIC HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TTI MEDICAL 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Contact | Allen R Howes |
| Correspondent | Allen R Howes TTI MEDICAL 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-28 |
| Decision Date | 1995-05-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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