FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IRRIGATION KIT
K Number: K883506
·
Decision Dec 13, 1988
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
40
Applicant Total
6
Review Days
118
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Basic Information
- Device Name
- IRRIGATION KIT
- K Number
- K883506
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6960
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- L H M Ent., Inc.
- Date Received
- August 17, 1988
- Decision Date
- December 13, 1988
- Product Code
- KYZ
- 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 |
|---|---|---|---|
| KYZ | Syringe, Irrigating (Non Dental) | FDA class 1 | General Hospital |
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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 |
| K900439 | SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC | Feb 15, 1990 | Substantially Equivalent |
| K894611 | CATHETER CARE KITS | Dec 15, 1989 | Unknown |