FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE HYPODERMIC NEEDLES
K Number: K821529
·
Decision Jun 9, 1982
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
6
Review Days
19
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Basic Information
- Device Name
- DISPOSABLE HYPODERMIC NEEDLES
- K Number
- K821529
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medcare Disp Products, Inc.
- Date Received
- May 21, 1982
- Decision Date
- June 9, 1982
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | 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 |
| K821528 | SYRINGE, PISTON | Jun 9, 1982 | Substantially Equivalent |
| K821530 | SYRINGE IRRIGATING | May 28, 1982 | Substantially Equivalent |