Device Classification Name |
powered laser surgical instrument |
|||
---|---|---|---|---|
510(k) Number | K023954 | |||
Device Name | ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES | |||
Original Applicant |
|
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Original Contact | kathy maynor | |||
Regulation Number | 878.4810 | |||
Classification Product Code |
|
|||
Date Received | 11/27/2002 | |||
Decision Date | 03/18/2003 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
General & Plastic Surgery |
|||
510k Review Panel |
General & Plastic Surgery |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |