FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COTTON UNDER CAST PADDING
K Number: K800195
·
Decision Feb 11, 1980
Classifications
1
FEI Numbers
239
Registration Numbers
239
Same Product Code
36
Applicant Total
11
Review Days
13
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Basic Information
- Device Name
- COTTON UNDER CAST PADDING
- K Number
- K800195
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3025
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Winn Hirsch & Assoc.
- Date Received
- January 29, 1980
- Decision Date
- February 11, 1980
- Product Code
- ITG
- 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 |
|---|---|---|---|
| ITG | Bandage, Cast | FDA class 1 | Physical Medicine |
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Other Clearances by Winn Hirsch & Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K880309 | TYPE 316L STAINLESS STEEL WIRE | Feb 29, 1988 | Substantially Equivalent |
| K864375 | TYPE 316L COTTER WIRE | May 20, 1987 | Substantially Equivalent for Some Indications |
| K832213 | GAUZE CONVERSION CLASS II STERILE | Jul 26, 1983 | Substantially Equivalent |
| K832214 | GAUZE CONVERSION CLASS I-NON-STERILE | Jul 26, 1983 | Substantially Equivalent |
| K830511 | ZANLEX, ZAN-TEX & ZANDEX | Mar 17, 1983 | Substantially Equivalent |
| K812391 | NEUROSPONGES | Nov 24, 1981 | Substantially Equivalent |
| K812390 | NEUROSPONGE PADDIE | Nov 24, 1981 | Substantially Equivalent |
| K761155 | CELLULOSE EYE STICK | Dec 16, 1976 | Substantially Equivalent |
| K760513 | ELECTRODE, TEMPORARY MYOCARDIAL | Oct 15, 1976 | Substantially Equivalent |
| K760365 | BLANKET, BURN | Aug 11, 1976 | Substantially Equivalent |