FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STP SYSTEM - SAF
K Number: K964026
·
Decision Nov 7, 1996
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
31
Review Days
31
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Basic Information
- Device Name
- STP SYSTEM - SAF
- K Number
- K964026
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sage Products, Inc.
- Date Received
- October 7, 1996
- Decision Date
- November 7, 1996
- Product Code
- LIO
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LIO | Device, Specimen Collection | FDA class 1 | Microbiology |
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Other Clearances by Sage Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972705 | RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC | Apr 30, 1998 | Substantially Equivalent |
| K980490 | SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS | Feb 24, 1998 | Substantially Equivalent |
| K973911 | 2 GALLON ALTERNATE CARE SHARPS CONTAINER | Oct 29, 1997 | Substantially Equivalent |
| K972279 | SHARPS SHUTTLE | Aug 29, 1997 | Substantially Equivalent |
| K970135 | NITRILE GLOVES | Aug 25, 1997 | Substantially Equivalent |
| K972302 | POCKET COUNT OR SAFETCOUNT | Jul 25, 1997 | Substantially Equivalent |
| K964168 | PROCEDURE SPECIFIC KITS | Mar 3, 1997 | Substantially Equivalent |
| K963986 | STP SYSTEM PVA WITH ZINC | Nov 8, 1996 | Substantially Equivalent |
| K964027 | STP SYSTEM-PVA WITH MERCURY | Nov 1, 1996 | Substantially Equivalent |
| K962168 | MUCUS SPECIMEN TRAP | Jul 22, 1996 | Substantially Equivalent |