FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SANG-A PETROLATUM GAUZE USP STERILE
K Number: K843035
·
Decision Sep 20, 1984
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
6
Review Days
49
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Basic Information
- Device Name
- SANG-A PETROLATUM GAUZE USP STERILE
- K Number
- K843035
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Tech-Cons Ltd., Intl.
- Date Received
- August 2, 1984
- Decision Date
- September 20, 1984
- Product Code
- FRO
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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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 |
| 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 |
| K842227 | AIMED DISPOSABLE SYRINGE, VARIOUS SIZES | Jul 23, 1984 | Substantially Equivalent |