FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
C-SECTION TRAY
K Number: K940518
·
Decision Aug 18, 1994
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
5
Applicant Total
23
Review Days
195
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Basic Information
- Device Name
- C-SECTION TRAY
- K Number
- K940518
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Cush Medical Products
- Date Received
- February 4, 1994
- Decision Date
- August 18, 1994
- Product Code
- MLS
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| MLS | Labor And Delivery Kit | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MLS), ordered by most recent decision date.
BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)
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CPR C-SECTION DELIVERY PACK
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C-SECTION, LABOR & DELIVERY TRAYS (PACKS)
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LABOR AND DELIVERY TRAY
FDA 510(k)
FDA Class 2
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CARAPACE LABOR AND DELIVERY SETS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Cush Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K943424 | CUSH ISLAND DRESSING | Oct 3, 1994 | Substantially Equivalent for Some Indications |
| K941349 | DENTAL TRAY | Jul 26, 1994 | Substantially Equivalent for Some Indications |
| K941645 | BIOPSY TRAY | Jul 14, 1994 | Unknown |
| K940239 | EYE TRAY | Jun 28, 1994 | Unknown |
| K935684 | IV START KIT | Jun 10, 1994 | Unknown |
| K941455 | STERILE GAUZE PRODUCT LINE | May 20, 1994 | Unknown |
| K941522 | STERILE X-RAY DETECTABLE GAUZE SPONGES | May 12, 1994 | Substantially Equivalent |
| K941344 | LAP SPONGE PRODUCT LINE | May 12, 1994 | Substantially Equivalent |
| K935697 | CIRCUMCISION TRAY | May 2, 1994 | Unknown |
| K936120 | LABOR AND DELIVERY TRAY | Mar 30, 1994 | Unknown |