510(k) K942896
K942896 is an FDA 510(k) premarket notification submitted by Surgin Surgical Instrumentation, Inc. for the device "CLAMPS AND CLIPS". The FDA issued a decision of Substantially Equivalent on Jul 19, 1994. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Surgin Surgical Instrumentation, Inc. has 22 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 19, 1994
- Date Received
- Jun 20, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Manual, Surgical, General Use
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt