The following data is part of a premarket notification filed by Wells Johnson Co. with the FDA for Bircoll Balloon Dissector.
| Device ID | K984448 |
| 510k Number | K984448 |
| Device Name: | BIRCOLL BALLOON DISSECTOR |
| Classification | Expander, Skin, Inflatable |
| Applicant | WELLS JOHNSON CO. 8000 SOUTH KOLB RD. Tucson, AZ 85706 |
| Contact | Ken Rodenburg |
| Correspondent | Ken Rodenburg WELLS JOHNSON CO. 8000 SOUTH KOLB RD. Tucson, AZ 85706 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-14 |
| Decision Date | 1999-01-28 |