FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECIMEN COLLECTION PAN
K Number: K800309
·
Decision Feb 26, 1980
Classifications
1
FEI Numbers
294
Registration Numbers
294
Same Product Code
22
Applicant Total
31
Review Days
14
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Basic Information
- Device Name
- SPECIMEN COLLECTION PAN
- K Number
- K800309
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Sage Products, Inc.
- Date Received
- February 12, 1980
- Decision Date
- February 26, 1980
- Product Code
- FMH
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| FMH | Container, Specimen, Sterile | FDA class 1 | Pathology |
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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 |