510(k) K822145
K822145 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical Ind., Inc. for the device "COMPLETE". The FDA issued a decision of Substantially Equivalent on October 22, 1982. The device falls under product code FZQ (Clip, Removable (Skin)), a Class I device regulated under 21 CFR 878.4320. Richard-Allan Medical Ind., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 1982
- Date Received
- July 21, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Removable (Skin)
- Device Class
- Class I
- Regulation Number
- 878.4320
- Review Panel
- SU
- Submission Type