MAMMARY SIZER
FDA 510(k) clearance K961356 · decided 1996-09-23
Clearance details
- K-number
- K961356
- Device name
- MAMMARY SIZER
- Applicant
- General Surgical Innovations
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1996-04-08
- Decision date
- 1996-09-23
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- MRD
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.