FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES
K Number: K912022
·
Decision Aug 2, 1991
Classifications
1
FEI Numbers
502
Registration Numbers
502
Same Product Code
106
Applicant Total
23
Review Days
87
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Basic Information
- Device Name
- FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES
- K Number
- K912022
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fraass Survival Systems, Inc.
- Date Received
- May 7, 1991
- Decision Date
- August 2, 1991
- Product Code
- NAD
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Fraass Survival Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871437 | SURVIVAL KIT, INDIVIDUAL | Jul 9, 1987 | Substantially Equivalent |
| K871434 | MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S | Jul 9, 1987 | Substantially Equivalent |
| K871458 | SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW | Jul 9, 1987 | Substantially Equivalent |
| K871917 | FRASTEC DRY GAUZE BANDAGE | Jun 16, 1987 | Substantially Equivalent for Some Indications |
| K871916 | FRASTEC DRY BURN DRESSING | Jun 16, 1987 | Substantially Equivalent for Some Indications |
| K871376 | FIRST AID KIT, VARIOUS SIZES | Jun 4, 1987 | Unknown |
| K871501 | KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE | Jun 2, 1987 | Substantially Equivalent |
| K871457 | FIRST AID KIT, EYE DRESSING | May 29, 1987 | Unknown |
| K871438 | BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52 | May 6, 1987 | Substantially Equivalent |
| K870240 | COMPRESS AND SKULLCAP, HEAD DRESSING | Feb 20, 1987 | Substantially Equivalent |