TEMP-GUARD TM
FDA 510(k) clearance K790948 · decided 1979-09-24
Clearance details
- K-number
- K790948
- Device name
- TEMP-GUARD TM
- Applicant
- Gordon Consultants, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-05-21
- Decision date
- 1979-09-24
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- FMT
- Device class
- 2
- Regulation number
- 880.5130
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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.