510(k) K893829
- Device
- POWERED EYE WASH
- Applicant
- SACKS MODEL MAKERS
- 510(k) number
- K893829
- Product code
- MSI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-11-14
- Date received
- 1989-05-24
- Regulation
- 510(k) Premarket Notification
- Classification name
- Solution, Cleaning / Lubricating, Artificial Eye
- 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
- Ophthalmic
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HERMAN SACKS
- Address
- 509 Skyline Lks. Dr. Ringwood NJ US 07456 07456
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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