FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
CUSH ISLAND DRESSING
K Number: K943424
·
Decision Oct 3, 1994
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
79
Applicant Total
23
Review Days
80
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Basic Information
- Device Name
- CUSH ISLAND DRESSING
- K Number
- K943424
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Cush Medical Products
- Date Received
- July 15, 1994
- Decision Date
- October 3, 1994
- Product Code
- MGP
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MGP | Dressing, Wound And Burn, Occlusive | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MGP), ordered by most recent decision date.
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FASTSEAL CHEST WOUND DRESSING
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SIMPLICARE TRANSPARENT WOUND DRESSING
FDA 510(k)
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DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Cush Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K940518 | C-SECTION TRAY | Aug 18, 1994 | Unknown |
| 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 |