510(k) K861806
- Device
- MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)
- Applicant
- MEDCOMP TECHNOLOGIES, INC.
- 510(k) number
- K861806
- Product code
- KDA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-05-23
- Date received
- 1986-05-09
- Regulation
- 878.3500
- Classification name
- Prosthesis, Ptfe/carbon-fiber
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILDEMAN
- Address
- 2555 Baird Rd. Penfield NY US 14526 14526
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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