510(k) K013151
K013151 is an FDA 510(k) premarket notification submitted by Bkg Opthalmics USA, Inc. for the device "ASMOTOM AUTOMATED TREPHINE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 14, 2001. The device falls under product code HRG (Engine, Trephine, Accessories, Ac-Powered), a Class I device regulated under 21 CFR 886.4070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2001
- Date Received
- September 20, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Engine, Trephine, Accessories, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.4070
- Review Panel
- OP
- Submission Type