SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25— 510(k) K981693
Substantially EquivalentGebauer Co.
FDA 510(k) clearance K981693 for SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25, Substantially Equivalent on 2001-08-06. Applicant: Gebauer Co.. Device class: Unclassified.
Clearance details
- Applicant
- Gebauer Co.
- Product code
- Code LFD
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
Recent devices under product code LFD
view allMore clearances from Gebauer Co.
view all- K032671 — GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07
- K031036 — GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03
- K021726 — GEBAUER'S INSTANT ICE
- K002596 — GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
- K001624 — GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04
Adverse events under product code LFD
product code LFD- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.