FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEKALB
K Number: K944414
·
Decision Sep 27, 1994
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
15
Review Days
19
Basic Information
- Device Name
- DEKALB
- K Number
- K944414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ENDOTEC, INC.
- Date Received
- September 8, 1994
- Decision Date
- September 27, 1994
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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| K960425 | BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX | Oct 3, 1996 | Substantially Equivalent |
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| K945254 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES | Jun 6, 1995 | Substantially Equivalent |
| K944465 | CARRIER, LIGATURE (79 GEJ) | Sep 28, 1994 | Substantially Equivalent |