FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MEDSURG MARSHMALLOW TRAY
K Number: K920421
·
Decision Dec 13, 1993
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
41
Review Days
682
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Basic Information
- Device Name
- MEDSURG MARSHMALLOW TRAY
- K Number
- K920421
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Medsurg Industries, Inc.
- Date Received
- January 31, 1992
- Decision Date
- December 13, 1993
- Product Code
- GAT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Medsurg Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920780 | MEDSURG INSERTION TRAY | Aug 19, 1994 | Unknown |
| K940175 | MEDSURG STERILE O.R. TOWELS | May 26, 1994 | Substantially Equivalent |
| K934731 | MEDSURG STERILE IMAGING PRODUCTS | Mar 28, 1994 | Substantially Equivalent |
| K925558 | INFILTUBE | Mar 4, 1994 | Substantially Equivalent |
| K934971 | STERILE LAPAROTOMY SPONGES | Feb 7, 1994 | Substantially Equivalent |
| K920838 | MEDSURG CIRCUMCISION TRAY | Oct 15, 1993 | Substantially Equivalent |
| K931932 | DRESSING CHANGE TRAY-MODIFIED | Aug 27, 1993 | Unknown |
| K914037 | MEDSURG O.R. PROCEDURE TRAY | Jun 22, 1993 | Unknown |
| K914036 | MEDSURG LAPAROSCOPY TRAY | Mar 18, 1992 | Substantially Equivalent |
| K893938 | CONTINUOUS EPIDURAL ANESTHESIA TRAY | Aug 7, 1989 | Substantially Equivalent |