FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KELLY CHOLANGIOCATH
K Number: K833920
·
Decision Dec 27, 1983
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
6
Review Days
43
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Basic Information
- Device Name
- KELLY CHOLANGIOCATH
- K Number
- K833920
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Perry, Div.
- Date Received
- November 14, 1983
- Decision Date
- December 27, 1983
- Product Code
- FGE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Perry, Div.
| K Number | Device Name | ||
|---|---|---|---|
| K851226 | I.V. START KIT | May 1, 1985 | Substantially Equivalent |
| K844610 | PERRY SUTURING SET W/ANESTHETIC | Jan 29, 1985 | Substantially Equivalent |
| K844609 | PERRY SUTURING SET | Jan 15, 1985 | Substantially Equivalent |
| K844001 | LANCE BLADES & SCALPELS | Nov 8, 1984 | Substantially Equivalent |
| K843125 | PERRY DERMAGUARD SURGICAL GLOVES | Sep 25, 1984 | Substantially Equivalent |