FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II
K Number: K901369
·
Decision Jun 5, 1990
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
9
Review Days
74
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Basic Information
- Device Name
- GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II
- K Number
- K901369
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Sterling Drug, Inc.
- Date Received
- March 23, 1990
- Decision Date
- June 5, 1990
- Product Code
- KGN
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
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Other Clearances by Sterling Drug, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K780209 | DILUTION SPIKE | Apr 10, 1978 | Substantially Equivalent |