FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEROYAL SURGICAL, UMBILICUP
K Number: K020753
·
Decision Jun 13, 2002
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
15
Applicant Total
5
Review Days
98
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Basic Information
- Device Name
- DEROYAL SURGICAL, UMBILICUP
- K Number
- K020753
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9100
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Deroyal
- Date Received
- March 7, 2002
- Decision Date
- June 13, 2002
- Product Code
- KSR
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | FDA class 2 | Hematology |
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Other Clearances by Deroyal
| K Number | Device Name | ||
|---|---|---|---|
| K041416 | EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER | Jul 2, 2004 | Substantially Equivalent |
| K033057 | DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE | Nov 20, 2003 | Substantially Equivalent |
| K031408 | DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) | Oct 15, 2003 | Substantially Equivalent |
| K030908 | DEROYAL SURGICAL DRAPES BACKTABLE COVER | Aug 11, 2003 | Substantially Equivalent |