Product code FZH— General, Plastic Surgery
CARDIO-PAK LAPAROTOMY PACK
- Classification name
- Apparatus, Air Handling, Room
- Device class
- Class 2
- Regulation
- 21 CFR 878.5070
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 4
- First cleared
- Most recent
Market context for product code FZH
FDA has cleared devices under product code FZH between 1977 and 1993, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1993
- 1988
- 1987
- 1977
Top applicants under product code FZH
Recent clearances under product code FZH
Data sourced from openFDA. This site is unofficial and independent of the FDA.