510(k) K820115
K820115 is an FDA 510(k) premarket notification submitted by Proto-Med, Inc. for the device "EMMETT IUD THREAD RETREIVER". The FDA issued a decision of Substantially Equivalent on February 5, 1982. 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
- February 5, 1982
- Date Received
- January 18, 1982
- 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