510(k) K896303
K896303 is an FDA 510(k) premarket notification submitted by Premier Medical for the device "BIOPSY PUNCH". The FDA issued a decision of Substantially Equivalent on February 13, 1990. The device falls under product code LRY (Punch, Surgical), a Class I device regulated under 21 CFR 878.4800. Premier Medical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1990
- Date Received
- October 30, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Punch, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type