FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REUSABLE LIQUIDPROOF BOOTIE
K Number: K925815
·
Decision Jul 9, 1993
Classifications
1
FEI Numbers
282
Registration Numbers
282
Same Product Code
35
Applicant Total
12
Review Days
234
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Basic Information
- Device Name
- REUSABLE LIQUIDPROOF BOOTIE
- K Number
- K925815
- 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
- Amsco Sterile Recoveries, Inc.
- Date Received
- November 17, 1992
- Decision Date
- July 9, 1993
- Product Code
- FXP
- 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 |
|---|---|---|---|
| FXP | Cover, Shoe, Operating-Room | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FXP), ordered by most recent decision date.
PRIMED SHOE COVERS, PRIMED HEAD COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FAR-EAST SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CONVERTORS IMPERVIOUS SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SHOE COVER, NON-STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIOMED SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Amsco Sterile Recoveries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932522 | AMSCO STERILE RECOVERIES SURGICAL PACKS | Sep 9, 1994 | Substantially Equivalent |
| K931143 | AMSCO STERILE RECOVERIES ABSORBENT TOWELS | Sep 8, 1994 | Substantially Equivalent |
| K931146 | SURGICAL DRAPES, MODIFICATION | Jun 13, 1994 | Substantially Equivalent |
| K931875 | AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE | Jun 10, 1994 | Substantially Equivalent |
| K931874 | RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE | Jun 10, 1994 | Substantially Equivalent |
| K931145 | NON-STERILE ISOLATION GOWN | Jun 10, 1994 | Substantially Equivalent |
| K931144 | STERILE SURGEON'S GOWN, MODIFICATION | Jun 10, 1994 | Substantially Equivalent |
| K932035 | NON-LINTING DELIVERY BLANKET | May 26, 1994 | Substantially Equivalent |
| K921049 | SURGICAL DRAPE | Oct 1, 1992 | Substantially Equivalent |
| K920405 | STERILE SURGEON'S GOWN | Aug 18, 1992 | Substantially Equivalent |