FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPR D & C TRAY
K Number: K960239
·
Decision May 23, 1996
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
41
Applicant Total
21
Review Days
128
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Basic Information
- Device Name
- CPR D & C TRAY
- K Number
- K960239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1175
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Custom Pack Reliability
- Date Received
- January 16, 1996
- Decision Date
- May 23, 1996
- Product Code
- HHK
- 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 |
|---|---|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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FDA 510(k)
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Other Clearances by Custom Pack Reliability
| K Number | Device Name | ||
|---|---|---|---|
| K960205 | CPR TRACHEOTOMY CARE TRAY | Aug 27, 1996 | Substantially Equivalent |
| K960243 | CPR C-SECTION DELIVERY PACK | May 23, 1996 | Substantially Equivalent |
| K960216 | CPR SUCTION CATHETER KIT | Apr 15, 1996 | Substantially Equivalent |
| K960211 | CPR TOTAL KNEE PACK | Apr 12, 1996 | Substantially Equivalent |
| K960210 | CPR ORTHO HAND PACK | Apr 12, 1996 | Substantially Equivalent |
| K960206 | CPR DRESSING CHANGE TRAY | Apr 12, 1996 | Substantially Equivalent |
| K960213 | CPR TOTAL HIP PACK | Apr 12, 1996 | Substantially Equivalent |
| K960209 | CPR HEART PACK | Apr 4, 1996 | Substantially Equivalent |
| K960214 | CPR FOLEY CAHTETER KIT | Apr 1, 1996 | Substantially Equivalent |
| K960212 | CPR IRRIGATION TRAY | Apr 1, 1996 | Substantially Equivalent |