FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDLINE OPEN END FINGER CONTROL MITT
K Number: K963504
·
Decision Oct 29, 1996
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
133
Applicant Total
11
Review Days
56
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Basic Information
- Device Name
- MEDLINE OPEN END FINGER CONTROL MITT
- K Number
- K963504
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6760
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medline
- Date Received
- September 3, 1996
- Decision Date
- October 29, 1996
- Product Code
- FMQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMQ | Restraint, Protective | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMQ), ordered by most recent decision date.
PROTECTIVE RESTRAINT
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COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
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INFANT LIMB HOLDER, MODELS 306080 & 306081
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CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
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| K970282 | MEDLINE CIRCUMCISION TRAY | Mar 6, 1997 | Substantially Equivalent |
| K963452 | MEDLINE ZIPPER SLEEVED VEST | Oct 18, 1996 | Substantially Equivalent |
| K951736 | LOCK-UP | Jul 5, 1995 | Substantially Equivalent |
| K932033 | LAPAROSCOPIC SURGERY INSTRUMENTS | Jun 19, 1995 | Substantially Equivalent |
| K932060 | MARTIN COLD LIGHT FOUNTAIN | Mar 30, 1994 | Substantially Equivalent |
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