SECURET DRAPE & INSTRUMENT RETAINER/INCL
FDA 510(k) clearance K830276 · decided 1983-03-29
Clearance details
- K-number
- K830276
- Device name
- SECURET DRAPE & INSTRUMENT RETAINER/INCL
- Applicant
- Ritmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-25
- Decision date
- 1983-03-29
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- GTC
- Device class
- 1
- Regulation number
- 866.3340
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.