The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Baloon Inflation Device.
| Device ID | K053188 |
| 510k Number | K053188 |
| Device Name: | REPROCESSED BALOON INFLATION DEVICE |
| Classification | Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Bruce R Lester |
| Correspondent | Bruce R Lester STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | NKU |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-15 |
| Decision Date | 2006-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551040389 | K053188 | 000 |
| 10888551040372 | K053188 | 000 |
| 10888551012881 | K053188 | 000 |
| 10888551012850 | K053188 | 000 |
| 10888551001083 | K053188 | 000 |
| 10888551001076 | K053188 | 000 |