FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE BAG DECANTER
K Number: K934179
·
Decision May 23, 1994
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
27
Review Days
270
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Basic Information
- Device Name
- DISPOSABLE BAG DECANTER
- K Number
- K934179
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Byron Medical
- Date Received
- August 26, 1993
- Decision Date
- May 23, 1994
- Product Code
- KPE
- 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 |
|---|---|---|---|
| KPE | Container, I.V. | FDA class 2 | General Hospital |
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Other Clearances by Byron Medical
| K Number | Device Name | ||
|---|---|---|---|
| K040149 | PSI-TEC PERISTALTIC INFILTRATION PUMP | Jun 3, 2004 | Substantially Equivalent |
| K001803 | ACCELERATOR RECIPROCATING CANNULA | Aug 4, 2000 | Substantially Equivalent |
| K981215 | PSI-TEC LIPOSUCTION ASPIRATOR | Jul 1, 1998 | Substantially Equivalent |
| K981172 | LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES | Jun 30, 1998 | Substantially Equivalent |
| K980738 | PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION | Jun 16, 1998 | Substantially Equivalent |
| K980392 | PSI-TEC ASPIRATOR | Mar 5, 1998 | Substantially Equivalent |
| K974295 | BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING | Feb 10, 1998 | Substantially Equivalent |
| K973133 | BIG BAG 3000 PRESSURE INFUSOR | Sep 12, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K934233 | ZARA ZONE IV MALAR IMPLANT MODIFICATION | Feb 3, 1994 | Substantially Equivalent |
| K933670 | BIOPSY PUNCH, SURGICAL | Jan 7, 1994 | Substantially Equivalent |