FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYRINGE IRRIGATING
K Number: K821530
·
Decision May 28, 1982
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
40
Applicant Total
6
Review Days
7
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Basic Information
- Device Name
- SYRINGE IRRIGATING
- K Number
- K821530
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6960
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medcare Disp Products, Inc.
- Date Received
- May 21, 1982
- Decision Date
- May 28, 1982
- 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 Medcare Disp Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841949 | DOSE RELEASE OF STERILIZATION LOTS | Sep 5, 1984 | Substantially Equivalent |
| K841405 | INJECTION CAP OR ADAPTOR | Apr 4, 1984 | Unknown |
| K840924 | SYRINGE, PISTON, ARTERIAL BLOOD SAMPL | Mar 23, 1984 | Substantially Equivalent |
| K821529 | DISPOSABLE HYPODERMIC NEEDLES | Jun 9, 1982 | Substantially Equivalent |
| K821528 | SYRINGE, PISTON | Jun 9, 1982 | Substantially Equivalent |