FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLOTH-HYPOALLERGENIC
K Number: K840947
·
Decision Aug 17, 1984
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
11
Review Days
165
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Basic Information
- Device Name
- CLOTH-HYPOALLERGENIC
- K Number
- K840947
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Gainor Medical
- Date Received
- March 5, 1984
- Decision Date
- August 17, 1984
- Product Code
- KGX
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGX), ordered by most recent decision date.
SERAGARD INJECTION PATCH
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SYVEK PATCH
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ADHESIVE BANDAGES WITH OTC DRUG
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TARGETT PATCH
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PARALLEL
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Other Clearances by Gainor Medical
| K Number | Device Name | ||
|---|---|---|---|
| K850100 | BLOOD LANCET | Jan 29, 1987 | Substantially Equivalent |
| K850150 | ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED | Feb 21, 1985 | Substantially Equivalent |
| K844306 | GAINOR MEDICAL SYRINGE | Nov 30, 1984 | Substantially Equivalent |
| K844305 | GAINOR MEDICAL FLOWMAX NEEDLES | Nov 30, 1984 | Substantially Equivalent |
| K840951 | FIRST AID BANDAGE | Oct 31, 1984 | Substantially Equivalent |
| K840950 | ZINC OXIDE TAPE | Oct 31, 1984 | Substantially Equivalent |
| K840945 | SKIN CLOSURE | Oct 31, 1984 | Substantially Equivalent |
| K840949 | CLEAR PLASTIC-HYPOALLERGENIC | Aug 17, 1984 | Substantially Equivalent |
| K840946 | MICROPOROUS HYPOALLERGENIC | Aug 17, 1984 | Substantially Equivalent |
| K840948 | CLEAR POROUS PLASTIC-HYPOALLERGENIC | Aug 14, 1984 | Substantially Equivalent |