FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
K Number: K032438
·
Decision Jun 30, 2004
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
39
Applicant Total
14
Review Days
328
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Basic Information
- Device Name
- MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
- K Number
- K032438
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tyco Healthcare
- Date Received
- August 7, 2003
- Decision Date
- June 30, 2004
- Product Code
- NGT
- 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 |
|---|---|---|---|
| NGT | Saline, Vascular Access Flush | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K070653 | KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 | Sep 12, 2007 | Substantially Equivalent |
| K061492 | MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE | Aug 3, 2006 | Substantially Equivalent |
| K042709 | DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER | Jan 18, 2005 | Substantially Equivalent |
| K040897 | DOVER ROB-NEL CATHETER | Jul 20, 2004 | Substantially Equivalent |
| K040649 | KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE | Jul 15, 2004 | Substantially Equivalent |
| K041243 | DOVER RED RUBBER ROBINSON CATHETER | Jul 7, 2004 | Substantially Equivalent |
| K033453 | KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING | Apr 29, 2004 | Substantially Equivalent |
| K032827 | KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 | Dec 8, 2003 | Substantially Equivalent |