FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPEN HEART TRAY (CUSTOM DESIGNED)
K Number: K822158
·
Decision Oct 13, 1982
Classifications
1
FEI Numbers
329
Registration Numbers
330
Same Product Code
61
Applicant Total
7
Review Days
82
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Basic Information
- Device Name
- OPEN HEART TRAY (CUSTOM DESIGNED)
- K Number
- K822158
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Megaplast, Inc.
- Date Received
- July 23, 1982
- Decision Date
- October 13, 1982
- Product Code
- KDD
- 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 |
|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Megaplast, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K810251 | SYRINGE, ENT | Mar 11, 1981 | Substantially Equivalent |