FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
K Number: K030721
·
Decision Mar 31, 2003
Classifications
1
FEI Numbers
165
Registration Numbers
165
Same Product Code
109
Applicant Total
26
Review Days
24
Basic Information
- Device Name
- QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
- K Number
- K030721
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BALLARD MEDICAL PRODUCTS
- Date Received
- March 7, 2003
- Decision Date
- March 31, 2003
- Product Code
- LRO
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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| K974630 | 72 HOUR USE TRACH CARE WITH MICROBAN | Mar 11, 1998 | Substantially Equivalent |
| K964369 | TRACH CARE SET WITH MICROBAN | Feb 11, 1997 | Substantially Equivalent |
| K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | Jul 5, 1995 | Substantially Equivalent |
| K923487 | BAL CATH | Jul 30, 1993 | Unknown |