FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VINYL ICE BAG
K Number: K810653
·
Decision Mar 27, 1981
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
3
Applicant Total
6
Review Days
17
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Basic Information
- Device Name
- VINYL ICE BAG
- K Number
- K810653
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6050
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- First Industries, Inc.
- Date Received
- March 10, 1981
- Decision Date
- March 27, 1981
- Product Code
- KYR
- 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 |
|---|---|---|---|
| KYR | Bag, Ice | FDA class 1 | General Hospital |
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Other Clearances by First Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K810651 | ORAL AIRWAYS | Mar 31, 1981 | Substantially Equivalent |
| K810652 | TUBING CONNECTORS | Mar 31, 1981 | Substantially Equivalent |
| K810654 | STOPPERLESS HOT/COLD RUBBER WATER BOTTLE | Mar 27, 1981 | Substantially Equivalent |
| K810649 | INVALID CUSHION | Mar 26, 1981 | Substantially Equivalent |
| K810650 | CRUTCH TIPS & GRIPS | Mar 26, 1981 | Substantially Equivalent |