510(k) K810282
K810282 is an FDA 510(k) premarket notification submitted by Minnesota Scientific, Inc. for the device "OPERATING TABLE ACCESSORY CLAMP". The FDA issued a decision of Substantially Equivalent on February 26, 1981. The device falls under product code GBJ (Prosthesis, Adhesive, External), a Class I device regulated under 21 CFR 878.3750. Minnesota Scientific, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1981
- Date Received
- February 2, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Adhesive, External
- Device Class
- Class I
- Regulation Number
- 878.3750
- Review Panel
- SU
- Submission Type