FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DILUTION SPIKE
K Number: K780209
·
Decision Apr 10, 1978
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
9
Review Days
63
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Basic Information
- Device Name
- DILUTION SPIKE
- K Number
- K780209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Sterling Drug, Inc.
- Date Received
- February 6, 1978
- Decision Date
- April 10, 1978
- 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 Sterling Drug, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901369 | GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II | Jun 5, 1990 | Substantially Equivalent |
| K896110 | BIOBRANE(R) II | Nov 28, 1989 | Substantially Equivalent |
| K875275 | WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER | Jan 27, 1988 | Substantially Equivalent |
| K840260 | PERIOGRAF DURAPATITE 40-60 MESH | Apr 5, 1984 | Substantially Equivalent |
| K820164 | EMPTY STERILE CARPUJECT | Feb 24, 1982 | Substantially Equivalent |
| K820023 | CONAGRAF TM DURAPATITE CONES | Feb 24, 1982 | Substantially Equivalent |
| K813257 | ALVEOGRAF DURAPATITE(18-40 MESH) | Jan 5, 1982 | Substantially Equivalent |
| K813070 | PERIOGRAF | Nov 20, 1981 | Substantially Equivalent |