FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP
K Number: K940371
·
Decision Apr 6, 1994
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
40
Applicant Total
29
Review Days
90
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Basic Information
- Device Name
- SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP
- K Number
- K940371
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6960
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Micromedics, Inc.
- Date Received
- January 6, 1994
- Decision Date
- April 6, 1994
- Product Code
- KYZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KYZ | Syringe, Irrigating (Non Dental) | FDA class 1 | General Hospital |
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