FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
K Number: K041563
·
Decision Aug 27, 2004
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
49
Applicant Total
1
Review Days
78
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
- OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
- K Number
- K041563
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Glaxosmithkline Consumer Healthcare, L.P.
- Date Received
- June 10, 2004
- Decision Date
- August 27, 2004
- Product Code
- LFD
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LFD | Saliva, Artificial | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFD), ordered by most recent decision date.
Allday Moisturizing Rinse
FDA 510(k)
FDA Unclassified
·Unknown
CloSYS® Dry Mouth Sensitive Mouth Rinse
FDA 510(k)
FDA Unclassified
·Unknown
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
FDA 510(k)
FDA Unclassified
·Unknown
Caphosol® Artifical Saliva (32 doses sachet box)
FDA 510(k)
FDA Unclassified
·Unknown
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
FDA 510(k)
FDA Unclassified
·Unknown
Dentilube Spray
FDA 510(k)
FDA Unclassified
·Unknown