FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
GASTROTEC
K Number: K954401
·
Decision Apr 25, 1996
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
1
Review Days
218
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Basic Information
- Device Name
- GASTROTEC
- K Number
- K954401
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Patrick C. Jacobssen
- Date Received
- September 20, 1995
- Decision Date
- April 25, 1996
- Product Code
- ESI
- Advisory Committee
- Unknown
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ESI | Polymer, Natural-Absorbable Gelatin Material | FDA class 3 | Unknown |
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