510(k) K813462
K813462 is an FDA 510(k) premarket notification submitted by Ocean Medical Products, Ltd. for the device "MADAYAG TYPE NEEDLE". The FDA issued a decision of Substantially Equivalent on March 1, 1982. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Ocean Medical Products, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 1982
- Date Received
- December 11, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type