FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MULTIPLE SCRUB SUIT
K Number: K822483
·
Decision Sep 17, 1982
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
5
Applicant Total
5
Review Days
31
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Basic Information
- Device Name
- MULTIPLE SCRUB SUIT
- K Number
- K822483
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Surgilite Intl., Inc.
- Date Received
- August 17, 1982
- Decision Date
- September 17, 1982
- Product Code
- FXO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FXO | Suit, Surgical | FDA class 1 | General, Plastic Surgery |
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