FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)
K Number: K962938
·
Decision Oct 25, 1996
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
9
Review Days
88
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Basic Information
- Device Name
- EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)
- K Number
- K962938
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Excelsior Medical Corp.
- Date Received
- July 29, 1996
- Decision Date
- October 25, 1996
- Product Code
- FOZ
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by Excelsior Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130975 | SWABCAP AND SWABFLUSH | Dec 24, 2013 | Substantially Equivalent |
| K101270 | SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 | Feb 10, 2011 | Substantially Equivalent |
| K083508 | SWABCAP | Apr 28, 2009 | Substantially Equivalent |
| K082837 | STERILE FIELD SALINE PRE-FILLED SYRINGE(S) | Dec 18, 2008 | Substantially Equivalent |
| K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML | Feb 23, 2007 | Substantially Equivalent |
| K053120 | STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES | Dec 9, 2005 | Substantially Equivalent |
| K023740 | SYREX PRE-FILLED SYRINGE | May 13, 2003 | Substantially Equivalent |
| K942349 | MICROBORE EXTENSION SET | Feb 8, 1995 | Substantially Equivalent |