The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Mic-key Glow Profile Gastrostomy Replacement Kit.
| Device ID | K982894 |
| 510k Number | K982894 |
| Device Name: | MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Contact | E. Martin Chamberlain |
| Correspondent | E. Martin Chamberlain BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-17 |
| Decision Date | 1998-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651949449 | K982894 | 000 |
| 30680651949432 | K982894 | 000 |
| 10680651949391 | K982894 | 000 |
| 10680651949322 | K982894 | 000 |
| 10350770949441 | K982894 | 000 |
| 10350770949434 | K982894 | 000 |
| 10350770949397 | K982894 | 000 |
| 10350770949328 | K982894 | 000 |