FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
3M REMOVER LOTION PRODUCT NUMBER 86XX
K Number: K925618
·
Decision Mar 31, 1993
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
11
Applicant Total
49
Review Days
145
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Basic Information
- Device Name
- 3M REMOVER LOTION PRODUCT NUMBER 86XX
- K Number
- K925618
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4730
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- 3M Health Care, Ltd.
- Date Received
- November 6, 1992
- Decision Date
- March 31, 1993
- Product Code
- KOX
- 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 |
|---|---|---|---|
| KOX | Solvent, Adhesive Tape | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOX), ordered by most recent decision date.
SEPP ADHESIVE REMOVER
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CHAD LABS ADHESIVE BANDAGE REMOVER
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ALLKARE(TM) ADHESIVE REMOVER WIPE
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MEDI-SOL
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SKIN SUPPORT PREP PAD
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REMOVE ADHESIVE REMOVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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|---|---|---|---|
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| K941534 | MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM | Mar 6, 1995 | Substantially Equivalent |
| K941748 | STERI-VAC GAS STERILIZER MODEL 8XL | Dec 2, 1994 | Substantially Equivalent |
| K930681 | 3M PREVENTION FABRIC SURGICAL GOWN #78XX | Feb 10, 1994 | Substantially Equivalent |
| K932307 | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM | Jan 7, 1994 | Substantially Equivalent |
| K932422 | 3M TEGADERM HP TRANSPARENT DRESSING | Dec 27, 1993 | Substantially Equivalent |
| K932446 | INJECTION SITE | Nov 29, 1993 | Substantially Equivalent |
| K931968 | CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO | Nov 10, 1993 | Substantially Equivalent |
| K933006 | AVI INFUSION PUMPS, ADDITIONAL INTENDED USE | Oct 25, 1993 | Substantially Equivalent |