The following data is part of a premarket notification filed by Continental Medical Laboratories, Inc. with the FDA for G-tube Dressing Change Tray.
| Device ID | K905123 |
| 510k Number | K905123 |
| Device Name: | G-TUBE DRESSING CHANGE TRAY |
| Classification | Wound Dressing Kit |
| Applicant | CONTINENTAL MEDICAL LABORATORIES, INC. P.O. BOX 306 817 MOHR AVENUE Waterford, WI 53185 |
| Contact | Joseph Dunn |
| Correspondent | Joseph Dunn CONTINENTAL MEDICAL LABORATORIES, INC. P.O. BOX 306 817 MOHR AVENUE Waterford, WI 53185 |
| Product Code | MCY |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-14 |
| Decision Date | 1991-03-27 |