510(k) K923099
K923099 is an FDA 510(k) premarket notification submitted by Hydro-Med Products, Inc. for the device "X-RAY DRAPES". The FDA issued a decision of Substantially Equivalent on October 15, 1992. The device falls under product code IWQ (Curtain, Protective, Radiographic), a Class I device regulated under 21 CFR 892.6500. Hydro-Med Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 1992
- Date Received
- June 25, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Curtain, Protective, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type