510(k) K812405
K812405 is an FDA 510(k) premarket notification submitted by Hydro-Med Products, Inc. for the device "STERILE TV CAMERA & CORD COVER". The FDA issued a decision of Substantially Equivalent on October 20, 1981. The device falls under product code KQM (Camera, Surgical And Accessories), a Class I device regulated under 21 CFR 878.4160. Hydro-Med Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1981
- Date Received
- August 21, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Surgical And Accessories
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type