510(k) K811761
K811761 is an FDA 510(k) premarket notification submitted by Proto-Med, Inc. for the device "THE EMMETT IUD THREAD RETRIEVER". The FDA issued a decision of Substantially Equivalent on September 21, 1981. The device falls under product code HHF (Remover, Intrauterine Device, Contraceptive, Hook-Type), a Class I device regulated under 21 CFR 884.4530. Proto-Med, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 1981
- Date Received
- June 22, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Remover, Intrauterine Device, Contraceptive, Hook-Type
- Device Class
- Class I
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type