FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SLOAN STA-DRI BOOTLEG LEGGING
K Number: K944276
·
Decision Jul 31, 1995
Classifications
1
FEI Numbers
801
Registration Numbers
801
Same Product Code
55
Applicant Total
3
Review Days
335
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SLOAN STA-DRI BOOTLEG LEGGING
- K Number
- K944276
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sloan Corp.
- Date Received
- August 30, 1994
- Decision Date
- July 31, 1995
- Product Code
- LYU
- 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 |
|---|---|---|---|
| LYU | Accessory, Surgical Apparel | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYU), ordered by most recent decision date.
STRYKER T4 HYTREL (R) TOGAS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NURSES BOUFFANT CAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FAR-EAST BOUFFANT CAPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE APRON
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DEPUY DISPOSABLE FILTER/HOOD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AMMI MAGNI-GUARD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery