FLEXI-LITE
Chamber, Hyperbaric
PRESSURE-TECH, INC.
The following data is part of a premarket notification filed by Pressure-tech, Inc. with the FDA for Flexi-lite.
Pre-market Notification Details
| Device ID | K101262 |
| 510k Number | K101262 |
| Device Name: | FLEXI-LITE |
| Classification | Chamber, Hyperbaric |
| Applicant | PRESSURE-TECH, INC. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Maria Griffin |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-05-05 |
| Decision Date | 2010-06-10 |
| Summary: | summary |
Trademark Results [FLEXI-LITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLEXI-LITE 85423158 4138987 Dead/Cancelled |
Typhoon Water Wares 2011-09-15 |
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