FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMSCO STERILE RECOVERIES ABSORBENT TOWELS
K Number: K931143
·
Decision Sep 8, 1994
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
12
Review Days
552
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Basic Information
- Device Name
- AMSCO STERILE RECOVERIES ABSORBENT TOWELS
- K Number
- K931143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Amsco Sterile Recoveries, Inc.
- Date Received
- March 5, 1993
- Decision Date
- September 8, 1994
- Product Code
- KKX
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Amsco Sterile Recoveries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932522 | AMSCO STERILE RECOVERIES SURGICAL PACKS | Sep 9, 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 |
| K925815 | REUSABLE LIQUIDPROOF BOOTIE | Jul 9, 1993 | Substantially Equivalent |
| K921049 | SURGICAL DRAPE | Oct 1, 1992 | Substantially Equivalent |
| K920405 | STERILE SURGEON'S GOWN | Aug 18, 1992 | Substantially Equivalent |