FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CP&S DISPOSABLE INSTANT COLD COMPRESS
K Number: K890553
·
Decision Feb 13, 1989
Classifications
1
FEI Numbers
377
Registration Numbers
377
Same Product Code
81
Applicant Total
7
Review Days
7
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Basic Information
- Device Name
- CP&S DISPOSABLE INSTANT COLD COMPRESS
- K Number
- K890553
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Consolidated Products & Services, Inc.
- Date Received
- February 6, 1989
- Decision Date
- February 13, 1989
- 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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Other Clearances by Consolidated Products & Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974190 | CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER | Nov 19, 1997 | Substantially Equivalent |
| K930759 | CP & S STERILE BURN SHEET | Jan 21, 1994 | Substantially Equivalent |
| K890551 | URINARY DRAINAGE UNIT | Feb 28, 1989 | Substantially Equivalent |
| K890550 | CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE) | Feb 28, 1989 | Substantially Equivalent |
| K890552 | CP&S GAVAGE CONSTAINER, DISPOSABLE | Feb 24, 1989 | Substantially Equivalent |
| K890554 | CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS | Feb 13, 1989 | Substantially Equivalent |