510(k) K863785
- Device
- Makler Catheter
- Applicant
- I M, INC.
- 510(k) number
- K863785
- Product code
- HDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-12-11
- Date received
- 1986-09-26
- Regulation
- 884.5250
- Classification name
- Cap, Cervical
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- AMIR PORAT
- Address
- P.O. Box 658 Fairfield NJ US 07004 07004
FDA Registration Numbers#
- 1216677
- 3003775072
- 3038597712
- 3005630901
- 1825146
- 2246552
- 3005136445
- 3013382619
- 1820334
- 9612445
Source Documents#
510(k) summary PDF not indicated by FDA
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