510(k) K942521

CONSERVA POST SYSTEM by Bull Frog Mfg. Co. — Product Code ELR

K942521 is an FDA 510(k) premarket notification submitted by Bull Frog Mfg. Co. for the device "CONSERVA POST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 8, 1994. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. Bull Frog Mfg. Co. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1994
Date Received
May 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Post, Root Canal
Device Class
Class I
Regulation Number
872.3810
Review Panel
DE
Submission Type