The following data is part of a premarket notification filed by Isovac Products, Llc with the FDA for Orca (tm) - Operational Rescue Containment Apparatus.
| Device ID | K163223 |
| 510k Number | K163223 |
| Device Name: | ORCA (tm) - Operational Rescue Containment Apparatus |
| Classification | Chamber, Patient Isolation |
| Applicant | ISOVAC PRODUCTS, LLC 1306 ENTERPRISE DRIVE, UNIT C Romeoville, IL 60446 |
| Contact | Peter M. Jenkner |
| Correspondent | Jeffery Jones JL JONES GROUP, INC 1213 KEVINGTON DRIVE Antioch, IL 60002 |
| Product Code | LGM |
| CFR Regulation Number | 880.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-16 |
| Decision Date | 2017-11-02 |
| Summary: | summary |