510(k) K820344
K820344 is an FDA 510(k) premarket notification submitted by New England Surgical Instrument Corp. for the device "ROWE SHOULDER INSTR. FOR BANKHART REPAIR". The FDA issued a decision of Substantially Equivalent on March 8, 1982. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800. New England Surgical Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1982
- Date Received
- February 8, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type