510(k) K980626
- Device
- Duration Ii Acetabular Components-gas Plasma Sterilization
- Applicant
- HOWMEDICA CORP.
- 510(k) number
- K980626
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-12-11
- Date received
- 1998-02-18
- Regulation
- 888.3350
- Classification name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- MARGARET F CROWE
- Address
- 359 Veterans Blvd. Rutherford NJ US 07070 07070
FDA Registration Numbers
- 1423662
- 1450662
- 1000200989
- 3002807090
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- 1833506
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Source Documents
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