FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUBOCCIPITAL ICE PILLOW
K Number: K882413
·
Decision Nov 30, 1988
Classifications
1
FEI Numbers
467
Registration Numbers
468
Same Product Code
26
Applicant Total
57
Review Days
170
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Basic Information
- Device Name
- SUBOCCIPITAL ICE PILLOW
- K Number
- K882413
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5700
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Ferguson Medical
- Date Received
- June 13, 1988
- Decision Date
- November 30, 1988
- Product Code
- IME
- 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 |
|---|---|---|---|
| IME | Pack, Hot Or Cold, Reusable | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
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| K970257 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES | May 22, 1997 | Substantially Equivalent |