FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
OMNI COLD GEL PACKS
K Number: K954877
·
Decision Feb 13, 1996
Classifications
1
FEI Numbers
377
Registration Numbers
377
Same Product Code
81
Applicant Total
5
Review Days
112
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Basic Information
- Device Name
- OMNI COLD GEL PACKS
- K Number
- K954877
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Omni Therm, Inc.
- Date Received
- October 24, 1995
- Decision Date
- February 13, 1996
- Product Code
- IMD
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | FDA class 1 | Physical Medicine |
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