MAMMARY SIZER
FDA 510(k) clearance K982258 · decided 1998-09-08
Clearance details
- K-number
- K982258
- Device name
- MAMMARY SIZER
- Applicant
- Specialty Surgical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-26
- Decision date
- 1998-09-08
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- MRD
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Hamilton, MT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.