FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PAD, POLYETHER FOAM, OPEN CELL
K Number: K760315
·
Decision Aug 11, 1976
Classifications
1
FEI Numbers
221
Registration Numbers
221
Same Product Code
38
Applicant Total
27
Review Days
16
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Basic Information
- Device Name
- PAD, POLYETHER FOAM, OPEN CELL
- K Number
- K760315
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5120
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Gaymar Industries, Inc.
- Date Received
- July 26, 1976
- Decision Date
- August 11, 1976
- Product Code
- FNJ
- 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 |
|---|---|---|---|
| FNJ | Bed, Manual | FDA class 1 | General Hospital |
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|---|---|---|---|
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| K962788 | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM | Apr 30, 1997 | Substantially Equivalent |
| K963067 | SOF. PRESS EPC 51 SYSTEM | Jan 28, 1997 | Substantially Equivalent |
| K961854 | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 | Aug 9, 1996 | Substantially Equivalent |
| K942881 | TC 3000 | May 23, 1995 | Substantially Equivalent |
| K930345 | TC2000 POWER UNIT AND ACCESSORIES | Aug 6, 1993 | Substantially Equivalent |
| K914921 | SCM-3 AND ACCESSORIES | Mar 12, 1992 | Substantially Equivalent |
| K914805 | TC-1000, TC-1050 SYSTEM | Jan 7, 1992 | Substantially Equivalent |
| K914851 | CLA-1400 SYSTEM | Nov 13, 1991 | Substantially Equivalent |