510(k) K920037
- Device
- OSTEO COMPRESSION HIP SCREW
- Applicant
- OSTEO AG
- 510(k) number
- K920037
- Product code
- HRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-11
- Date received
- 1992-01-06
- Regulation
- 886.5928
- Classification name
- Sterilizer, Soft-lens, Thermal, Battery-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRYSON, JR.
- Address
- 208 Wilson Bridge Rd. Greenwood SC US 29646 29646
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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