FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE
K Number: K930915
·
Decision Sep 29, 1994
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
22
Applicant Total
8
Review Days
583
Basic Information
- Device Name
- FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE
- K Number
- K930915
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GEBAUER CO.
- Date Received
- February 23, 1993
- Decision Date
- September 29, 1994
- Product Code
- MLY
- Advisory Committee
- Unknown
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| MLY | Vapocoolant Device | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MLY), ordered by most recent decision date.
DentalJect
FDA 510(k)
FDA Unclassified
·Unknown
PainFreeze II
FDA 510(k)
FDA Unclassified
·Unknown
CRYO Arctic, CRYO Penguin
FDA 510(k)
FDA Unclassified
·Unknown
num Vapocoolant
FDA 510(k)
FDA Unclassified
·Unknown
Syringe Holder accessory
FDA 510(k)
FDA Unclassified
·Unknown
Vapocoolshot Mist
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by GEBAUER CO.
| K Number | Device Name | ||
|---|---|---|---|
| K032671 | GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 | Mar 17, 2004 | Substantially Equivalent |
| K031036 | GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 | Jul 10, 2003 | Substantially Equivalent |
| K021726 | GEBAUER'S INSTANT ICE | Dec 12, 2002 | Substantially Equivalent |
| K981693 | SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 | Aug 6, 2001 | Substantially Equivalent |
| K002596 | GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 | Feb 15, 2001 | Substantially Equivalent |
| K001624 | GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 | Jan 25, 2001 | Substantially Equivalent |
| K991514 | GEBAUER'S CHLORIDE FINE NOZZE | Jul 16, 1999 | Substantially Equivalent |