FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ALUMINUM FOIL
K Number: K930401
·
Decision May 12, 1993
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
79
Applicant Total
9
Review Days
106
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Basic Information
- Device Name
- ALUMINUM FOIL
- K Number
- K930401
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gam Industries, Inc.
- Date Received
- January 26, 1993
- Decision Date
- May 12, 1993
- Product Code
- MGP
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MGP | Dressing, Wound And Burn, Occlusive | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MGP), ordered by most recent decision date.
COLLATEK FOAM
FDA 510(k)
FDA Unclassified
·Unknown
COLLATEK SHEET
FDA 510(k)
FDA Unclassified
·Unknown
LASERSKIN DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
FASTSEAL CHEST WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
SIMPLICARE TRANSPARENT WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Gam Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941641 | DISPOSABLE EMERGENCY OBSTETRICAL KIT | Oct 3, 1994 | Substantially Equivalent |
| K941336 | COMBO MASK | Sep 9, 1994 | Substantially Equivalent |
| K942021 | MOUTH TO MOUTH BREATHER | Jun 22, 1994 | Substantially Equivalent |
| K936050 | JAW SPREADER | Mar 24, 1994 | Substantially Equivalent |
| K926290 | BURN SHEET | Apr 20, 1993 | Substantially Equivalent |
| K925590 | MULTI-TRAUMA DRESSING | Apr 8, 1993 | Substantially Equivalent |
| K915569 | UMBILICAL CLAMP | Sep 23, 1992 | Substantially Equivalent |
| K915303 | FOIL BABY BUNTING | Feb 20, 1992 | Substantially Equivalent |