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 |