510(k) K063759
- Device
- HEATMARKER TIME TEMPERATURE INDICATOR
- Applicant
- TEMPTIME CORPORATION
- 510(k) number
- K063759
- Product code
- OCI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-08-15
- Date received
- 2006-12-19
- Regulation
- 880.2800
- Classification name
- Indicator, Physical/chemical, Storage Temperature
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD PHILLIPS
- Address
- 116 American Rd. Morris Plains NJ US 07950 07950
FDA Registration Numbers#
- 3004437723
Source Documents#
Legacy Summary#
summary
FDA Review#
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