FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GUAZE BANDAGES CAT.#101-169
K Number: K801996
·
Decision Sep 16, 1980
Classifications
1
FEI Numbers
570
Registration Numbers
570
Same Product Code
87
Applicant Total
31
Review Days
27
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Basic Information
- Device Name
- GUAZE BANDAGES CAT.#101-169
- K Number
- K801996
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Pollak (Intl.), Ltd.
- Date Received
- August 20, 1980
- Decision Date
- September 16, 1980
- Product Code
- NAB
- 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 |
|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NAB), ordered by most recent decision date.
IVALON EXTERNAL SPONGE
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ISOLYER (4X4, 8PLY)
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OMNISORB II, NONWOVEN SPONGE, STERILE AND NON
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MULTI-TRAUMA DRESSING
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K-BAND AND K-CREPE
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STERILE GAUZE PADS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Pollak (Intl.), Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K000227 | UMBICUT | Apr 27, 2000 | Substantially Equivalent |
| K810049 | PEDICAT* | Apr 21, 1981 | Substantially Equivalent |
| K810050 | VECAFIX* | Mar 26, 1981 | Substantially Equivalent |
| K802009 | FLOWCLAMP CAT.#1011 & 1012 | Oct 31, 1980 | Substantially Equivalent |
| K802011 | INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 | Oct 31, 1980 | Substantially Equivalent |
| K802017 | DRESSING CHANGE SET CAT.#910-930 | Oct 10, 1980 | Substantially Equivalent |
| K802007 | PEDIWET=GUAZE IMPREGNATED WITH PETROL | Sep 26, 1980 | Substantially Equivalent |
| K801991 | PLASTIC FORCEPS CAT.#1001-1010 | Sep 16, 1980 | Substantially Equivalent |
| K802021 | PEDIBAND CAT.#195-197 | Sep 16, 1980 | Substantially Equivalent |
| K802022 | STERILE GUAZE SWABS CAT.#301-420 | Sep 16, 1980 | Substantially Equivalent |