510(k) K863785
K863785 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "MAKLER CATHETER". The FDA issued a decision of Substantially Equivalent on December 11, 1986. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250. I M, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1986
- Date Received
- September 26, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cap, Cervical
- Device Class
- Class II
- Regulation Number
- 884.5250
- Review Panel
- OB
- Submission Type