FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-
K Number: K843539
·
Decision May 23, 1985
Classifications
1
FEI Numbers
206
Registration Numbers
206
Same Product Code
13
Applicant Total
3
Review Days
258
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-
- K Number
- K843539
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6050
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Molnlycke A/S Hospital Products
- Date Received
- September 7, 1984
- Decision Date
- May 23, 1985
- Product Code
- EFN
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EFN | Cotton, Roll | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFN), ordered by most recent decision date.
STRUNG DENTAL ROLLS
FDA 510(k)
FDA Class 1
·Dental
MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER
FDA 510(k)
FDA Class 1
·Dental
COTTON ROLLS, NON-STERILE
FDA 510(k)
FDA Class 1
·Dental
DENTAL COTTON ROLLS, STERILE AND NON-STERILE
FDA 510(k)
FDA Class 1
·Dental
COTTON FILLED GAUZE SPONGES 2 X 2
FDA 510(k)
FDA Class 1
·Dental
DENTAL COTTON ROLLS
FDA 510(k)
FDA Class 1
·Dental