510(k) K110625
- Device
- SAFETYMATE TALKING FIRST AID
- Applicant
- SAFETYMATE, INC.
- 510(k) number
- K110625
- Product code
- OVR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-06-17
- Date received
- 2011-03-04
- Regulation
- 878.4014
- Classification name
- Kit, First Aid, Talking
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHARON COHEN, PH.D
- Address
- 1633 Monrovia Ave. Costa Mcsa CA US 92627 92627
FDA Registration Numbers#
- 3037012186
- 3011656357
- 3010934856
- 3034629649
- 3007703436
- 3044466317
- 3025380425
- 3006897996
- 3010373263
- 3017201547
- 3012311599
- 3011767915
- 3017299525
- 1220908
- 2427500
- 3028013069
- 3005951243
- 3013735158
- 3016746538
- 3006113277
- 3011647251
- 3021630959
- 3024891479
- 3013530901
- 3031582440
- 3010166880
- 3019111927
- 3016452400
- 3008808560
- 2000018713
- 3029871637
- 3016601021
- 3033858895
- 3017181414
- 3012309743
Source Documents#
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases