ACRA-CUT
FDA 510(k) clearance K833266 · decided 1983-12-29
Clearance details
- K-number
- K833266
- Device name
- ACRA-CUT
- Applicant
- Acra Cut, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-21
- Decision date
- 1983-12-29
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- HBF
- Device class
- 2
- Regulation number
- 882.4305
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Acton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.