510(k) K902636
K902636 is an FDA 510(k) premarket notification submitted by Lipogen, Inc. for the device "LIPOGEN RHEUMELISA DSDNA ASSAY". The FDA issued a decision of Substantially Equivalent on June 28, 1990. The device falls under product code LRY (Punch, Surgical), a Class I device regulated under 21 CFR 878.4800. Lipogen, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1990
- Date Received
- June 14, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Punch, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type