510(k) K761193
K761193 is an FDA 510(k) premarket notification submitted by Superior Plastic Products Corp. for the device "SUTURE REMOVAL KIT". The FDA issued a decision of Substantially Equivalent on January 12, 1977. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Superior Plastic Products Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1977
- Date Received
- December 6, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Surgical Instrument, Disposable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type