CUSTOM STERILE PROCEDURE KITS
FDA 510(k) clearance K842356 · decided 1985-03-21
Clearance details
- K-number
- K842356
- Device name
- CUSTOM STERILE PROCEDURE KITS
- Applicant
- Sterile Design, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-15
- Decision date
- 1985-03-21
- Days to decision
- 279 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Oldsmar, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.