FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES
K Number: K870184
·
Decision Feb 6, 1987
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
23
Review Days
21
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Basic Information
- Device Name
- BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES
- K Number
- K870184
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Fraass Survival Systems, Inc.
- Date Received
- January 16, 1987
- Decision Date
- February 6, 1987
- Product Code
- FRO
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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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 |