The following data is part of a premarket notification filed by Isovac Products Llc with the FDA for Capsuls, Models 2003-pur8c, 2004-pvc8c.
| Device ID | K052798 |
| 510k Number | K052798 |
| Device Name: | CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C |
| Classification | Chamber, Patient Transport Isolation |
| Applicant | ISOVAC PRODUCTS LLC 540 COLLEGE ST Bellaire, TX 77401 |
| Contact | Lisa S Jones |
| Correspondent | Lisa S Jones ISOVAC PRODUCTS LLC 540 COLLEGE ST Bellaire, TX 77401 |
| Product Code | LGN |
| CFR Regulation Number | 880.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-03 |
| Decision Date | 2006-06-06 |
| Summary: | summary |