The following data is part of a premarket notification filed by Summit To Sea with the FDA for Dive And Shallow And Grand Dive.
| Device ID | K072757 |
| 510k Number | K072757 |
| Device Name: | DIVE AND SHALLOW AND GRAND DIVE |
| Classification | Chamber, Hyperbaric |
| Applicant | SUMMIT TO SEA 1744 AVOCET LANE Mound, MN 55364 |
| Contact | Bruce Mckeeman |
| Correspondent | Bruce Mckeeman SUMMIT TO SEA 1744 AVOCET LANE Mound, MN 55364 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-27 |
| Decision Date | 2008-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866115000324 | K072757 | 000 |
| 00866115000317 | K072757 | 000 |
| 00866115000300 | K072757 | 000 |