510(k) K771344
K771344 is an FDA 510(k) premarket notification submitted by J. Sklar Mfg. Co., Inc. for the device "GUSBERG HYSTERECTOMY CLAMP". The FDA issued a decision of Substantially Equivalent on July 27, 1977. The device falls under product code HGC (Clamp, Uterine), a Class I device regulated under 21 CFR 884.4520. J. Sklar Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1977
- Date Received
- July 13, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Uterine
- Device Class
- Class I
- Regulation Number
- 884.4520
- Review Panel
- OB
- Submission Type