FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SURGICAL ISOLATION BARRIER SYSTEM
K Number: K831531
·
Decision Jun 5, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
6
Review Days
391
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Basic Information
- Device Name
- SURGICAL ISOLATION BARRIER SYSTEM
- K Number
- K831531
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Lone Star Medical Products, Inc.
- Date Received
- May 11, 1983
- Decision Date
- June 5, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Lone Star Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850041 | P-3 CLOSING INSTRUMENT | Feb 21, 1985 | Substantially Equivalent |
| K820015 | URETHAL CUTTER CLAMP | Feb 22, 1982 | Substantially Equivalent |
| K810915 | THE SCOTT DIALMENZENSERT | May 8, 1981 | Substantially Equivalent |
| K802983 | THE INQUINAL RESORVOIR INSERTER | Dec 30, 1980 | Substantially Equivalent |
| K791665 | SCOTTS SURGICAL RETRACTOR AND ELASTIC | Sep 19, 1979 | Substantially Equivalent |