510(k) K800963
K800963 is an FDA 510(k) premarket notification submitted by Mr Associates, Inc. for the device "BIOPSY FORCEPS W/NEEDLE M.R. ASSOC.". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Mr Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 1980
- Date Received
- April 23, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Biopsy, Non-Electric
- Device Class
- Class I
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type