FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SURGIFRESH SURGICAL SMOKE REMOVAL
K Number: K870932
·
Decision Mar 31, 1987
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
30
Review Days
22
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Basic Information
- Device Name
- SURGIFRESH SURGICAL SMOKE REMOVAL
- K Number
- K870932
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Texas Medical Products, Inc.
- Date Received
- March 9, 1987
- Decision Date
- March 31, 1987
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Texas Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893417 | SURGIFRESH SUB-MICRON MASK NO. 901008-000 | Jun 22, 1989 | Substantially Equivalent |
| K851575 | DR. BRUNO LNAGE MINI PHOTOMETER | Oct 18, 1985 | Substantially Equivalent |
| K830634 | CARDIOTOMY FILTER | Jun 30, 1983 | Substantially Equivalent |
| K813587 | DISPOSABLE THORACIC CATHETER | Jan 12, 1982 | Substantially Equivalent |
| K810532 | DISPOSABLE STOPCOCK | Apr 23, 1981 | Substantially Equivalent |
| K810515 | DISPOSABLE 2-STAGE CANNULA | Apr 23, 1981 | Substantially Equivalent |
| K810395 | PRE-BYPASS FILTER | Mar 5, 1981 | Substantially Equivalent |
| K802545 | CARDIOPLEGIC SETS | Jan 16, 1981 | Substantially Equivalent |
| K802543 | RIDGID VENA CAVA CANNULAE | Jan 16, 1981 | Substantially Equivalent |
| K802544 | DISPOSABLE QUICK RELEASE PERFUSION ADAP | Jan 16, 1981 | Substantially Equivalent |