FDA 510(k)
Substantially Equivalent for Some Indications
🇺🇸 United States
THERAPY CASSETTS
K Number: K854920
·
Decision May 19, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
160
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Basic Information
- Device Name
- THERAPY CASSETTS
- K Number
- K854920
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Alpha Therapeutic Corp.
- Date Received
- December 10, 1985
- Decision Date
- May 19, 1986
- Product Code
- MCU
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Other Clearances by Alpha Therapeutic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K970225 | ALPHA MICRON 20/40 MICROAGGREGATE FILTER | Feb 14, 1997 | Substantially Equivalent |
| K955515 | ALPHA MICRON 20 MICROAGGREGATE FILTER | Feb 12, 1996 | Substantially Equivalent |
| K854441 | STUART GILMAN'S WEIGHT LOSS PLAN | Feb 10, 1986 | Substantially Equivalent |
| K833294 | ALPHA Y-RECIPIENT SET | Dec 27, 1983 | Substantially Equivalent |
| K820447 | ALPHA PLASMA TRANSFER SET | Apr 14, 1982 | Substantially Equivalent |
| K810897 | ALPHA PLASTIC PLASMA BOTTLE | Sep 23, 1981 | Substantially Equivalent |
| K810761 | ALPHA MICRON-40 FILTER | Jun 30, 1981 | Substantially Equivalent |