510(k) K921433
- Device
- ATTIC DEFECT PLATE
- Applicant
- SMITH & NEPHEW RICHARDS, INC.
- 510(k) number
- K921433
- Product code
- ETC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-03-18
- Date received
- 1992-03-25
- Regulation
- 874.3430
- Classification name
- Mold, Middle-ear
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS CRAIG
- Address
- 1450 Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers#
- 3003790304
- 3011050570
- 1037007
- 1928237
Source Documents#
Legacy Summary#
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FDA Review#
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