FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957)
K Number: K924834
·
Decision Mar 23, 1993
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
14
Applicant Total
5
Review Days
179
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Basic Information
- Device Name
- PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957)
- K Number
- K924834
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- American Healthcare Supply Co., Inc.
- Date Received
- September 25, 1992
- Decision Date
- March 23, 1993
- Product Code
- MCZ
- 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 |
|---|---|---|---|
| MCZ | Suture Removal Kit | FDA class 1 | General, Plastic Surgery |
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