FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHUR-LOCK ICE WRAP SYSTEM
K Number: K904819
·
Decision Dec 6, 1990
Classifications
1
FEI Numbers
377
Registration Numbers
377
Same Product Code
81
Applicant Total
12
Review Days
43
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Basic Information
- Device Name
- SHUR-LOCK ICE WRAP SYSTEM
- K Number
- K904819
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Conco Medical Co.
- Date Received
- October 24, 1990
- Decision Date
- December 6, 1990
- 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 Conco Medical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K821701 | RAPIDO-LASTIC IN STERILE FORM | Jul 22, 1982 | Substantially Equivalent |
| K820826 | STAX FINGER SPLINT | Apr 8, 1982 | Substantially Equivalent |
| K820381 | FINGER PROTECTOR | Mar 1, 1982 | Substantially Equivalent |
| K820382 | FROG SPLINT | Mar 1, 1982 | Substantially Equivalent |
| K820380 | CURVED FINGER SPLINT | Mar 1, 1982 | Substantially Equivalent |
| K820383 | FINGER COT | Feb 24, 1982 | Substantially Equivalent |
| K760139 | BANDAGE, E-COTTON ELASTIC | Jul 19, 1976 | Substantially Equivalent |
| K760138 | BANDAGE, CEB COTTON ELASTIC | Jul 19, 1976 | Substantially Equivalent |
| K760140 | BANDAGE, WRINKY-LASTIC ELASTIC GAUZE | Jul 19, 1976 | Substantially Equivalent |
| K760142 | BANDAGE, RAPIDO-LASTIC COTTON/NYLON | Jul 19, 1976 | Substantially Equivalent |