FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INJECTION CAP
K Number: K913337
·
Decision Feb 11, 1992
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
31
Review Days
200
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Basic Information
- Device Name
- INJECTION CAP
- K Number
- K913337
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cp Medical
- Date Received
- July 26, 1991
- Decision Date
- February 11, 1992
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Cp Medical
| K Number | Device Name | ||
|---|---|---|---|
| K094028 | CP-FIBER (ORTHOFIBER) | Mar 18, 2010 | Substantially Equivalent |
| K072229 | MONOSWIFT | Oct 5, 2007 | Substantially Equivalent |
| K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS | Jul 18, 2007 | Substantially Equivalent |
| K060987 | OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 | Nov 2, 2006 | Substantially Equivalent |
| K041894 | ORTHOFIBER | Sep 17, 2004 | Substantially Equivalent |
| K034062 | CP SLEEVE AND RIVER SLEEVE | Jan 30, 2004 | Substantially Equivalent |
| K024372 | CP MEDICAL BONE WAX | Jun 19, 2003 | Substantially Equivalent |
| K030786 | MONO-SWIFT | May 6, 2003 | Substantially Equivalent |
| K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | Mar 28, 2003 | Substantially Equivalent |
| K023710 | VISORB SWIFT | Jan 17, 2003 | Substantially Equivalent |