FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MATTRESSES, CONDUCTIVE & COVERS
K Number: K780033
·
Decision Feb 21, 1978
Classifications
1
FEI Numbers
210
Registration Numbers
210
Same Product Code
13
Applicant Total
10
Review Days
43
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Basic Information
- Device Name
- MATTRESSES, CONDUCTIVE & COVERS
- K Number
- K780033
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6190
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Chase Mfg. Co.
- Date Received
- January 9, 1978
- Decision Date
- February 21, 1978
- Product Code
- FMW
- 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 |
|---|---|---|---|
| FMW | Cover, Mattress (Medical Purposes) | FDA class 1 | General Hospital |
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Other Clearances by Chase Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K791513 | ADAMCO DUST COVER | Oct 11, 1979 | Substantially Equivalent |
| K790993 | INSTANT HOT & COLD PACKS | Sep 7, 1979 | Substantially Equivalent |
| K790644 | SUBMAX | Apr 26, 1979 | Substantially Equivalent |
| K771792 | ENEMA SET | Oct 20, 1977 | Substantially Equivalent |
| K771791 | NEEDLE COUNTING | Oct 4, 1977 | Substantially Equivalent |
| K770900 | CAST BRWM, FRACTURE | Jul 21, 1977 | Substantially Equivalent |
| K770898 | FRACTURE CAST BRACE KIT, PLASTIC | Jul 21, 1977 | Substantially Equivalent |
| K770899 | FRACTURE CAST BRACE, POLY | Jul 21, 1977 | Substantially Equivalent |
| K770173 | STOCKINETTE | Feb 8, 1977 | Substantially Equivalent |