510(k) K830189
K830189 is an FDA 510(k) premarket notification submitted by Temp Medical Products, Inc. for the device "CARDIOVASCULAR SAW BLADES". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code DWH (Blade, Saw, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 878.4820. Temp Medical Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1983
- Date Received
- January 19, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blade, Saw, Surgical, Cardiovascular
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type