510(k) K955717
- Device
- ENDOSCOPE INTRODUCER KIT
- Applicant
- MITSUBISHI CABLE AMERICA, INC.
- 510(k) number
- K955717
- Product code
- FDE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-18
- Date received
- 1995-12-18
- Regulation
- 876.1500
- Classification name
- Laparoscopy Kit
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD J EHMSEN
- Address
- 10551 Wulff Dr. Villa Park CA US 92667 92667
FDA Registration Numbers#
- 3015173212
- 3015612252
- 1423537
- 3035642068
- 9611102
- 3007329020
- 3009888344
- 3004362278
- 3003418325
- 1060680
- 1418479
- 2320762
- 1043214
- 1030451
- 2029015
- 3007289408
- 1423395
- 3008513424
- 1055236
- 2431166
- 3004111573
- 3015058854
- 1643817
- 3004605321
- 9616088
- 2433012
- 3015895045
- 1047429
- 3011137372
- 1054241
- 3005012805
- 3004911384
- 3001675293
- 1061124
- 1928237
- 3015241782
- 3010041511
- 3004122598
- 3005595283
Source Documents#
Other 510(k) Records For Product Code FDE #
Legacy Summary#
summary
FDA Review#
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