510(k) K822392
- Device
- MYOCUR BLADE PAC
- Applicant
- MYOCURE, INC.
- 510(k) number
- K822392
- Product code
- HMN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-25
- Date received
- 1982-08-09
- Regulation
- 510(k) Premarket Notification
- Classification name
- Suture, Nonabsorable, Ophthalmic
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3004944585
- 3013187142
- 3007205024
- 3018052045
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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