FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GELIPERM GRANULES
K Number: K823225
·
Decision Aug 12, 1983
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
16
Review Days
287
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Basic Information
- Device Name
- GELIPERM GRANULES
- K Number
- K823225
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Geistlich-Pharma
- Date Received
- October 29, 1982
- Decision Date
- August 12, 1983
- Product Code
- FRO
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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| K974399 | BIO-OSS COLLAGEN | Sep 16, 1998 | Substantially Equivalent |
| K970321 | BIO-OSS ANORGANIC BOVINE BONE | Sep 15, 1998 | Substantially Equivalent |
| K972817 | RESOR-PIN RESORBABLE MEMBRANE PIN | Jul 24, 1998 | Substantially Equivalent |
| K960724 | BIO-GIDE RESORBABLE BILAYER MEMBRANE | Jun 11, 1997 | Substantially Equivalent |
| K952619 | BIO-OSS CERAMIC | Aug 28, 1995 | Substantially Equivalent |
| K952618 | BIO-OSS | Aug 28, 1995 | Substantially Equivalent |
| K952617 | BIO-OSS | Aug 7, 1995 | Substantially Equivalent |