The following data is part of a premarket notification filed by Cpac, Inc. with the FDA for Steri-dent, Steri-sure.
Device ID | K094026 |
510k Number | K094026 |
Device Name: | STERI-DENT, STERI-SURE |
Classification | Sterilizer, Dry Heat |
Applicant | CPAC, INC. 2364 LEICESTER RD. P.O. BOX 175 Leicester, NY 14481 -0175 |
Contact | Jeffrey Crane |
Correspondent | Jeffrey Crane CPAC, INC. 2364 LEICESTER RD. P.O. BOX 175 Leicester, NY 14481 -0175 |
Product Code | KMH |
CFR Regulation Number | 880.6870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-30 |
Decision Date | 2011-07-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B234KMHSD301000230 | K094026 | 000 |
B234KMHSD301000115 | K094026 | 000 |
B234KMHSD201000230 | K094026 | 000 |
B234KMHSD201000115 | K094026 | 000 |