510(k) K842295
K842295 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "INTRAUTERINE DEVICE REMOVER". The FDA issued a decision of Substantially Equivalent on October 12, 1984. The device falls under product code HHF (Remover, Intrauterine Device, Contraceptive, Hook-Type), a Class I device regulated under 21 CFR 884.4530. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 1984
- Date Received
- June 11, 1984
- 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