FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GENT-L-KARE STERILE I.V. START KIT
K Number: K844255
·
Decision Dec 19, 1984
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
13
Review Days
47
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Basic Information
- Device Name
- GENT-L-KARE STERILE I.V. START KIT
- K Number
- K844255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Geneva Laboratories, Inc.
- Date Received
- November 2, 1984
- Decision Date
- December 19, 1984
- 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 Geneva Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K881217 | GENT-L-KARE STERILE URINARY LEG BAG | Jul 29, 1988 | Substantially Equivalent |
| K881213 | GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER | Jul 28, 1988 | Substantially Equivalent |
| K881218 | GENT-L-KARE CLEANSING ENEMA SET | Jul 28, 1988 | Substantially Equivalent |
| K881216 | GENT-L-KARE VAGINAL IRRIGATION SET | Jun 7, 1988 | Substantially Equivalent |
| K861308 | ACCUPAC CUSTOM PACK KERLIX SQUARES | May 2, 1986 | Substantially Equivalent |
| K861219 | ACCUPAC CUSTOM SKIN SCRUB KIT | Apr 15, 1986 | Substantially Equivalent |
| K853265 | ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 | Aug 26, 1985 | Substantially Equivalent |
| K843206 | COOK COUNTY HOSPITAL DRESSING CHANGE SET | May 24, 1985 | Substantially Equivalent |
| K843090 | UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM | Dec 4, 1984 | Substantially Equivalent |
| K830725 | GENT-L-SPEC DISPOS. VAGINAL SPECULUM | Apr 27, 1983 | Substantially Equivalent |