510(k) K803178
K803178 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "ANSPACH MENISECTOMY KNIFE". The FDA issued a decision of Substantially Equivalent on February 13, 1981. The device falls under product code FZS (Curette, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1981
- Date Received
- December 16, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Curette, Surgical, General Use
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type