COLOSTOMY DEVICE, MACLET MAGNETIC
FDA 510(k) clearance K782154 · decided 1979-06-21
Clearance details
- K-number
- K782154
- Device name
- COLOSTOMY DEVICE, MACLET MAGNETIC
- Applicant
- Maclet Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-12-22
- Decision date
- 1979-06-21
- Days to decision
- 181 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- 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.