FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATI(R) DISP BIOLOGICAL-PLUS TEST PACK
K Number: K925745
·
Decision Feb 1, 1994
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
205
Applicant Total
17
Review Days
445
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Basic Information
- Device Name
- ATI(R) DISP BIOLOGICAL-PLUS TEST PACK
- K Number
- K925745
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pymah Corp.
- Date Received
- November 13, 1992
- Decision Date
- February 1, 1994
- Product Code
- FRC
- 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 |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | FDA class 2 | General Hospital |
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Other Clearances by Pymah Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K952995 | ATI ETHYLENE OXIDE STERILIZATION INDICATOR | Feb 22, 1996 | Substantially Equivalent |
| K952408 | ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION | Jul 6, 1995 | Substantially Equivalent |
| K951063 | ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION | May 10, 1995 | Substantially Equivalent |
| K934874 | STERIGAGE EO 100% | Apr 18, 1995 | Substantially Equivalent |
| K943081 | TRIMLINE 2000 | Jan 27, 1995 | Substantially Equivalent |
| K925496 | ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK | Feb 1, 1994 | Substantially Equivalent |
| K934180 | SLIMLINE 3000 | Nov 24, 1993 | Substantially Equivalent |
| K924681 | GLUTARALDEHYDE MONITORS | Nov 17, 1993 | Substantially Equivalent |
| K925744 | TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF | Jul 30, 1993 | Substantially Equivalent |
| K930604 | BALANCED(TM) NYLON BLADDER | Apr 30, 1993 | Substantially Equivalent |