FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
2 FR KELMAN CHAMBER MAINTAINER
K Number: K792096
·
Decision Nov 16, 1979
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
9
Review Days
29
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Basic Information
- Device Name
- 2 FR KELMAN CHAMBER MAINTAINER
- K Number
- K792096
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Heyer Schulte Corp.
- Date Received
- October 18, 1979
- Decision Date
- November 16, 1979
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Heyer Schulte Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K790842 | SUBCUTANEOUS TISSUE EXPANDER | Aug 3, 1979 | Substantially Equivalent |
| K780706 | LUMBAR NERVE ROOT SHIELD | Sep 7, 1978 | Substantially Equivalent |
| K780417 | ASEPTIC TRANSFER SET | Apr 18, 1978 | Substantially Equivalent |
| K771224 | RADOVAN SUBCUTANEOUS TISSUE EXPANDER | Oct 11, 1977 | Substantially Equivalent |
| K760778 | T-TUBE DRAIN, ROUND | Nov 3, 1976 | Substantially Equivalent |
| K760785 | MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH | Nov 1, 1976 | Substantially Equivalent |
| K760784 | MISHLER 2 CHAMB FLUSHING VALVE,STAND | Nov 1, 1976 | Substantially Equivalent |
| K760501 | VALVE, STANDARD MODEL PUDENZE FLUSHING | Aug 30, 1976 | Substantially Equivalent |