510(k) K900665
K900665 is an FDA 510(k) premarket notification submitted by Healthdyne Cardiovascular, Inc. for the device "DRESSING CHANGE KIT". The FDA issued a decision of SN on May 14, 1990. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Healthdyne Cardiovascular, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- May 14, 1990
- Date Received
- February 13, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type