510(k) K770413
- Device
- CUSHIONS, DENTURE ADHESIVE, ALL-DAY
- Applicant
- Combe, Inc.
- 510(k) number
- K770413
- Product code
- EHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-06-24
- Date received
- 1977-03-04
- Regulation
- 872.3540
- Classification name
- Cushion, Denture, Over The Counter
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3023395601
- 3016447764
- 8020152
- 3011252807
- 3043303267
Source Documents#
510(k) summary PDF not indicated by FDA