FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEPTUNE WASTE MANAGEMENT SYSTEM
K Number: K990037
·
Decision Aug 24, 1999
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
74
Applicant Total
1
Review Days
230
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NEPTUNE WASTE MANAGEMENT SYSTEM
- K Number
- K990037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Immuno Tech
- Date Received
- January 6, 1999
- Decision Date
- August 24, 1999
- Product Code
- FYD
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FYD), ordered by most recent decision date.
PlumeSafe X5 Smoke Management System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
8Q10 Surclear Smoke Plume Evacuation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medline Smoke Evacuation Shroud
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEBULAE SRS Laparoscopic Surgical Smoke Removal System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EvaQMax Smoke Evacuation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery