The following data is part of a premarket notification filed by Sea-long Medical Systems, Inc. with the FDA for Sea-long Medical Treatment Hood.
| Device ID | K010659 |
| 510k Number | K010659 |
| Device Name: | SEA-LONG MEDICAL TREATMENT HOOD |
| Classification | Chamber, Hyperbaric |
| Applicant | SEA-LONG MEDICAL SYSTEMS, INC. 1983 SOUTH PARK RD. Louisville, KY 40219 |
| Contact | Gerald Cox |
| Correspondent | Gerald Cox SEA-LONG MEDICAL SYSTEMS, INC. 1983 SOUTH PARK RD. Louisville, KY 40219 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-06 |
| Decision Date | 2001-05-16 |