The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Entera-flo Spike Set.
| Device ID | K893209 |
| 510k Number | K893209 |
| Device Name: | ENTERA-FLO SPIKE SET |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | DELMED, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick, NJ 08903 |
| Contact | Ronald Guido |
| Correspondent | Ronald Guido DELMED, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick, NJ 08903 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-27 |
| Decision Date | 1989-07-24 |