FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYRINGE, ENT
K Number: K810251
·
Decision Mar 11, 1981
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
40
Applicant Total
7
Review Days
41
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Basic Information
- Device Name
- SYRINGE, ENT
- K Number
- K810251
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6960
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Megaplast, Inc.
- Date Received
- January 29, 1981
- Decision Date
- March 11, 1981
- Product Code
- KYZ
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KYZ | Syringe, Irrigating (Non Dental) | FDA class 1 | General Hospital |
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Other Clearances by Megaplast, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K822158 | OPEN HEART TRAY (CUSTOM DESIGNED) | Oct 13, 1982 | Substantially Equivalent |
| K821313 | SURGICAL UTILITY DRAPE | Jun 21, 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 |