FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE
K Number: K950956
·
Decision Jun 2, 1995
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
42
Applicant Total
26
Review Days
92
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Basic Information
- Device Name
- DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE
- K Number
- K950956
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5910
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Vascular, Inc.
- Date Received
- March 2, 1995
- Decision Date
- June 2, 1995
- Product Code
- GXQ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GXQ | Dura Substitute | FDA class 2 | Neurology |
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Other Clearances by Bio-Vascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002233 | BVI SLING | Oct 13, 2000 | Substantially Equivalent |
| K992537 | PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED | Feb 22, 2000 | Substantially Equivalent |
| K983602 | CV PERI-GUARD AND VASCU-GUARD | Nov 12, 1998 | Substantially Equivalent |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | Nov 6, 1998 | Substantially Equivalent |
| K983162 | PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC | Oct 9, 1998 | Substantially Equivalent |
| K981624 | FLO-THRU | Aug 4, 1998 | Substantially Equivalent |
| K982282 | DURA-GUARD - DURAL REPAIR PATCH | Jul 30, 1998 | Substantially Equivalent |
| K971726 | CV PERI-GUARD - CARDIOVASCULAR PATCH | Apr 10, 1998 | Substantially Equivalent |
| K973706 | DURA-GUARD-DURAL REPAIR PATCH | Dec 24, 1997 | Substantially Equivalent |
| K973552 | OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP | Dec 16, 1997 | Substantially Equivalent |