510(k) K802313
K802313 is an FDA 510(k) premarket notification submitted by Gynemetrics, Inc. for the device "UTERINE CURETTE". The FDA issued a decision of Substantially Equivalent on January 12, 1981. The device falls under product code HCY (Curette, Uterine), a Class I device regulated under 21 CFR 884.4530. Gynemetrics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1981
- Date Received
- September 23, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Curette, Uterine
- Device Class
- Class I
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type