510(k) K905583
K905583 is an FDA 510(k) premarket notification submitted by Inman Liebelt Corp. for the device "ILC FORCEPS PADS". The FDA issued a decision of Substantially Equivalent on April 12, 1991. The device falls under product code HDA (Forceps, Obstetrical), a Class II device regulated under 21 CFR 884.4400. Inman Liebelt Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1991
- Date Received
- December 12, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Obstetrical
- Device Class
- Class II
- Regulation Number
- 884.4400
- Review Panel
- OB
- Submission Type