FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)
K Number: K961993
·
Decision Jul 3, 1996
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
5
Applicant Total
47
Review Days
43
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Basic Information
- Device Name
- BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)
- K Number
- K961993
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Devon Industries, Inc.
- Date Received
- May 21, 1996
- Decision Date
- July 3, 1996
- 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.
CPR C-SECTION DELIVERY PACK
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C-SECTION TRAY
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C-SECTION, LABOR & DELIVERY TRAYS (PACKS)
FDA 510(k)
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·Obstetrics/Gynecology
LABOR AND DELIVERY TRAY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CARAPACE LABOR AND DELIVERY SETS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Devon Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954015 | ABG POINT LOK NEEDLE PROTECTION DEVICE | Nov 20, 1995 | Substantially Equivalent |
| K946289 | DEVONS POINT LOK NEEDLE PROTECTION DEVICE | Jul 10, 1995 | Substantially Equivalent |
| K945197 | THE SHARPS COLLECTION AND DISPOSAL SYSTEM | Dec 2, 1994 | Substantially Equivalent |
| K943892 | POINT OF USE SHARPS A GATOR | Dec 2, 1994 | Substantially Equivalent |
| K944114 | PHLEBOTOMY UNIT SHARPS A GATOR | Dec 2, 1994 | Substantially Equivalent |
| K945485 | ABG NEEDLE PROTECTION | Nov 29, 1994 | Substantially Equivalent |
| K932998 | EASY-ON | Aug 18, 1993 | Substantially Equivalent |
| K912824 | DEVON SPONGE COUNTER BAGS | Aug 26, 1991 | Substantially Equivalent |
| K894170 | DEVON DISPOSABLE HEAD POSITIONER COVER | Sep 7, 1989 | Substantially Equivalent |
| K892660 | HIBERNATION KIT | Aug 15, 1989 | Substantially Equivalent |