AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS
FDA 510(k) clearance K954652 · decided 1996-02-14
Clearance details
- K-number
- K954652
- Device name
- AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1995-10-10
- Decision date
- 1996-02-14
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- South San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.