FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)
K Number: K972747
·
Decision Jan 9, 1998
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
205
Applicant Total
25
Review Days
170
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Basic Information
- Device Name
- BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)
- K Number
- K972747
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Propper Mfg. Co., Inc.
- Date Received
- July 23, 1997
- Decision Date
- January 9, 1998
- 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 Propper Mfg. Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111453 | STEAM DOT BLU PROCESS INDICATOR | Apr 5, 2012 | Substantially Equivalent |
| K102894 | CLASSIX CHEMICAL STERILIZATION INDICATOR | May 25, 2011 | Substantially Equivalent |
| K082620 | ONCE-A-DAY VERTOS TEST PACK | Jul 8, 2009 | Substantially Equivalent |
| K031152 | PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) | Aug 17, 2004 | Substantially Equivalent |
| K991618 | BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR | Jan 24, 2001 | Substantially Equivalent |
| K991276 | PASS/FAIL CHALLENGE PACK | Jul 12, 1999 | Substantially Equivalent |
| K973585 | PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR | Nov 6, 1998 | Substantially Equivalent |
| K961156 | ONCE-A-DAY BOWIE AND DICK TEST PACK. | Apr 1, 1997 | Substantially Equivalent |
| K921798 | PROPPER SUPER SERACULT(R) | Oct 5, 1992 | Substantially Equivalent |
| K915804 | PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM. | Mar 20, 1992 | Substantially Equivalent |