FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIMED DISPOSABLE SYRINGE, VARIOUS SIZES
K Number: K842227
·
Decision Jul 23, 1984
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
6
Review Days
48
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Basic Information
- Device Name
- AIMED DISPOSABLE SYRINGE, VARIOUS SIZES
- K Number
- K842227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Tech-Cons Ltd., Intl.
- Date Received
- June 5, 1984
- Decision Date
- July 23, 1984
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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Other Clearances by Tech-Cons Ltd., Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K843117 | GREEN CROSS URINARY DRAINAGE BAG | Oct 11, 1984 | Substantially Equivalent |
| K843035 | SANG-A PETROLATUM GAUZE USP STERILE | Sep 20, 1984 | Substantially Equivalent |
| K842228 | AIMED FOLEY CATHETER VARIOUS SIZES | Sep 10, 1984 | Substantially Equivalent |
| K842255 | AIMED SCALP VEIN SET VARIOUS | Aug 17, 1984 | Substantially Equivalent |
| K842230 | AIMED DISPOS. INJECTION NEEDLE | Aug 17, 1984 | Substantially Equivalent |