FDA 510(k)
Substantially Equivalent
🇺🇸 United States
EXU-DRY BURN-TRAUMA DRESSING-VARIOUS
K Number: K840498
·
Decision May 30, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
23
Review Days
114
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Basic Information
- Device Name
- EXU-DRY BURN-TRAUMA DRESSING-VARIOUS
- K Number
- K840498
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Fraass Survival Systems, Inc.
- Date Received
- February 6, 1984
- Decision Date
- May 30, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Fraass Survival Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912022 | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES | Aug 2, 1991 | Substantially Equivalent |
| 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 |