FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL UTILITY DRAPE
K Number: K821313
·
Decision Jun 21, 1982
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
7
Review Days
48
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Basic Information
- Device Name
- SURGICAL UTILITY DRAPE
- K Number
- K821313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Megaplast, Inc.
- Date Received
- May 4, 1982
- Decision Date
- June 21, 1982
- Product Code
- FJZ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FJZ | Declotting Tray, Kit (Including Contents) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FJZ), ordered by most recent decision date.
STERILE SURGICAL DRAPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DECOLLATING TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Megaplast, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K822158 | OPEN HEART TRAY (CUSTOM DESIGNED) | Oct 13, 1982 | Substantially Equivalent |
| K820423 | SUTURE REMOVAL TRAY | Mar 10, 1982 | Substantially Equivalent |
| K820136 | URINARY DRAINAGE BAG | Jan 29, 1982 | Substantially Equivalent |
| K810249 | TRAY, CATHERIZATION, URETHRAL | Apr 7, 1981 | Substantially Equivalent |
| K810250 | TRAY, IRRIGATION | Apr 7, 1981 | Substantially Equivalent |
| K810251 | SYRINGE, ENT | Mar 11, 1981 | Substantially Equivalent |