FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC
K Number: K900439
·
Decision Feb 15, 1990
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
6
Review Days
17
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Basic Information
- Device Name
- SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC
- K Number
- K900439
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- L H M Ent., Inc.
- Date Received
- January 29, 1990
- Decision Date
- February 15, 1990
- Product Code
- FIH
- 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 |
|---|---|---|---|
| FIH | Pump, Infusion Or Syringe, Extra-Luminal | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by L H M Ent., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901078 | SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE | May 18, 1990 | Substantially Equivalent |
| K901079 | SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER | May 18, 1990 | Substantially Equivalent |
| K894610 | CUSTOM TRAYS, KITS | Mar 15, 1990 | Unknown |
| K894611 | CATHETER CARE KITS | Dec 15, 1989 | Unknown |
| K883506 | IRRIGATION KIT | Dec 13, 1988 | Substantially Equivalent |