510(k) K790577
K790577 is an FDA 510(k) premarket notification submitted by J. Sklar Mfg. Co., Inc. for the device "HEMORRHOIDAL LIGATOR". The FDA issued a decision of Substantially Equivalent on April 23, 1979. The device falls under product code HCF (Instrument, Ligature Passing And Knot Tying), a Class I device regulated under 21 CFR 878.4800. J. Sklar Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1979
- Date Received
- March 28, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ligature Passing And Knot Tying
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type