510(k) K842111
K842111 is an FDA 510(k) premarket notification submitted by J. Sklar Mfg. Co., Inc. for the device "KOGAN ENDOSPECULUM 9-1/2". The FDA issued a decision of Substantially Equivalent on Jun 19, 1984. The device falls under product code HTZ (Instrument, Cutting, Orthopedic), a Class I device regulated under 21 CFR 878.4800. J. Sklar Mfg. Co., Inc. has 17 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 19, 1984
- Date Received
- May 29, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Instrument, Cutting, Orthopedic
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt