FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
3M MAXI-DRIVER II DBATTERY POWERED SYSTEM
K Number: K932307
·
Decision Jan 7, 1994
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
28
Applicant Total
49
Review Days
241
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Basic Information
- Device Name
- 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM
- K Number
- K932307
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- 3M Health Care, Ltd.
- Date Received
- May 11, 1993
- Decision Date
- January 7, 1994
- Product Code
- KIJ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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|---|---|---|---|
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| K941748 | STERI-VAC GAS STERILIZER MODEL 8XL | Dec 2, 1994 | Substantially Equivalent |
| K930681 | 3M PREVENTION FABRIC SURGICAL GOWN #78XX | Feb 10, 1994 | Substantially Equivalent |
| K932422 | 3M TEGADERM HP TRANSPARENT DRESSING | Dec 27, 1993 | Substantially Equivalent |
| K932446 | INJECTION SITE | Nov 29, 1993 | Substantially Equivalent |
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| K933006 | AVI INFUSION PUMPS, ADDITIONAL INTENDED USE | Oct 25, 1993 | Substantially Equivalent |
| K933005 | AVI MODEL 600 SYRINGE PUMP | Oct 25, 1993 | Substantially Equivalent |