The following data is part of a premarket notification filed by Blue Sky Bio, Llc with the FDA for Blue Sky Bio Plan, Version .38.
| Device ID | K090607 |
| 510k Number | K090607 |
| Device Name: | BLUE SKY BIO PLAN, VERSION .38 |
| Classification | System, Image Processing, Radiological |
| Applicant | BLUE SKY BIO, LLC 888 E BELVIDERE RD. SUITE 212 Grayslake, IL 60030 |
| Contact | Albert Zickmann |
| Correspondent | Albert Zickmann BLUE SKY BIO, LLC 888 E BELVIDERE RD. SUITE 212 Grayslake, IL 60030 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-06 |
| Decision Date | 2009-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815131026726 | K090607 | 000 |
| 00815131026412 | K090607 | 000 |