FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE BASIN SET
K Number: K844611
·
Decision Dec 19, 1984
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
13
Review Days
22
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Basic Information
- Device Name
- SINGLE BASIN SET
- K Number
- K844611
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Packaging Technologies, Inc.
- Date Received
- November 27, 1984
- Decision Date
- December 19, 1984
- Product Code
- FRG
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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Other Clearances by Packaging Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K881756 | STERILE SURGEONS GLOVES | Jun 1, 1988 | Substantially Equivalent |
| K863326 | BONE MARROW TRAY | Sep 16, 1986 | Substantially Equivalent |
| K861041 | ENHANCE | May 30, 1986 | Substantially Equivalent |
| K850544 | SHAVE PREP TRAY | Mar 12, 1985 | Substantially Equivalent |
| K850438 | RENAL BIOPSY TRAY | Feb 26, 1985 | Substantially Equivalent |
| K844613 | GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR | Jan 10, 1985 | Substantially Equivalent |
| K844614 | IV START KIT | Dec 19, 1984 | Substantially Equivalent |
| K844612 | ACUTE HEMODIALYSIS TRAYS | Dec 17, 1984 | Substantially Equivalent |
| K834074 | PERCUTANEOUS SHEATH INTRODUCER TRAY | Mar 19, 1984 | Substantially Equivalent |
| K834073 | CENTRAL VEIN CATHERIZATION TRAY CC-20 | Feb 28, 1984 | Substantially Equivalent |