FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DR. GOULD HAND PACK SUSTOM STERIL
K Number: K842405
·
Decision Aug 15, 1984
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
27
Review Days
57
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Basic Information
- Device Name
- DR. GOULD HAND PACK SUSTOM STERIL
- K Number
- K842405
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Pro-Lab, Inc.
- Date Received
- June 19, 1984
- Decision Date
- August 15, 1984
- Product Code
- FRG
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K903714 | E. COLI 0157 LATEX TEST | Jan 24, 1991 | Substantially Equivalent |
| K894221 | ROSCO PYRR | Sep 28, 1989 | Substantially Equivalent |
| K883995 | X-ACT UREA/TDA | Oct 12, 1988 | Substantially Equivalent |
| K883996 | X-ACT LDC/IND | Oct 12, 1988 | Substantially Equivalent |
| K871121 | PROTECT T.M. | Apr 14, 1987 | Substantially Equivalent |
| K870117 | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST | Mar 20, 1987 | Substantially Equivalent |
| K861142 | MASTER KIT B | Jul 10, 1986 | Unknown |