FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NON-LINTING DELIVERY BLANKET
K Number: K932035
·
Decision May 26, 1994
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
25
Applicant Total
12
Review Days
394
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Basic Information
- Device Name
- NON-LINTING DELIVERY BLANKET
- K Number
- K932035
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4900
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Amsco Sterile Recoveries, Inc.
- Date Received
- April 27, 1993
- Decision Date
- May 26, 1994
- Product Code
- KNC
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| KNC | Table, Obstetric (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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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 |
| 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 |
| 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 |