FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MUCUS SPECIMEN TRAP
K Number: K962168
·
Decision Jul 22, 1996
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
47
Applicant Total
31
Review Days
47
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Basic Information
- Device Name
- MUCUS SPECIMEN TRAP
- K Number
- K962168
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sage Products, Inc.
- Date Received
- June 5, 1996
- Decision Date
- July 22, 1996
- Product Code
- KDQ
- 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 |
|---|---|---|---|
| KDQ | Bottle, Collection, Vacuum | FDA class 2 | General Hospital |
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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 |
| K964026 | STP SYSTEM - SAF | Nov 7, 1996 | Substantially Equivalent |
| K964027 | STP SYSTEM-PVA WITH MERCURY | Nov 1, 1996 | Substantially Equivalent |