FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EXUSORB(TM) DRY/WET DRESSING
K Number: K896176
·
Decision Nov 24, 1989
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
21
Applicant Total
4
Review Days
30
Basic Information
- Device Name
- EXUSORB(TM) DRY/WET DRESSING
- K Number
- K896176
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4018
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- CONTROLLED THERAPEUTICS CORP.
- Date Received
- October 25, 1989
- Decision Date
- November 24, 1989
- Product Code
- KOZ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | FDA class 1 | General, Plastic Surgery |
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