510(k) K873038
K873038 is an FDA 510(k) premarket notification submitted by Techton, Inc. for the device "TECHTON PROTECTIVE PAD". The FDA issued a decision of Substantially Equivalent on April 3, 1989. The device falls under product code IWQ (Curtain, Protective, Radiographic), a Class I device regulated under 21 CFR 892.6500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 1989
- Date Received
- August 4, 1987
- 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