The following data is part of a premarket notification filed by Cpac, Inc. with the FDA for Dry Heat Sterilizer.
Device ID | K771070 |
510k Number | K771070 |
Device Name: | DRY HEAT STERILIZER |
Classification | Sterilizer, Dry Heat |
Applicant | CPAC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KMH |
CFR Regulation Number | 880.6870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-06-14 |
Decision Date | 1977-07-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B234KMHSS3100230V1 | K771070 | 000 |
B234KMHSS2100115V2 | K771070 | 000 |
M36883761 | K771070 | 000 |
M36883751 | K771070 | 000 |