The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for Acculite(tm) Otoprobe.
Device ID | K930981 |
510k Number | K930981 |
Device Name: | ACCULITE(TM) OTOPROBE |
Classification | Powered Laser Surgical Instrument |
Applicant | COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
Contact | Virginia Singer |
Correspondent | Virginia Singer COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-25 |
Decision Date | 1993-07-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17290109140855 | K930981 | 000 |
07290109140841 | K930981 | 000 |
17290109140831 | K930981 | 000 |
07290109140827 | K930981 | 000 |
17290109140817 | K930981 | 000 |