The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Hyperbaric Penetration Extension Set.
| Device ID | K861315 |
| 510k Number | K861315 |
| Device Name: | HYPERBARIC PENETRATION EXTENSION SET |
| Classification | Chamber, Hyperbaric |
| Applicant | CUTTER LABORATORIES, INC. FOURTH AND PARKER STREETS BOX 1986 Berkeley, CA 94710 |
| Contact | Steven J Ojala |
| Correspondent | Steven J Ojala CUTTER LABORATORIES, INC. FOURTH AND PARKER STREETS BOX 1986 Berkeley, CA 94710 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-08 |
| Decision Date | 1986-05-21 |