The following data is part of a premarket notification filed by Intermed, Inc. with the FDA for Intermed, Ins Sterile Water/saline.
| Device ID | K842166 |
| 510k Number | K842166 |
| Device Name: | INTERMED, INS STERILE WATER/SALINE |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | INTERMED, INC. 15 WHITE LAKE RD. Sparta, NJ 07871 |
| Contact | Norman T Ruedt |
| Correspondent | Norman T Ruedt INTERMED, INC. 15 WHITE LAKE RD. Sparta, NJ 07871 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-31 |
| Decision Date | 1985-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B150TRAC10020 | K842166 | 000 |
| B150TRAC10010 | K842166 | 000 |
| B15041290 | K842166 | 000 |
| B15041280 | K842166 | 000 |
| B15041200 | K842166 | 000 |
| B15041180 | K842166 | 000 |
| B15027650 | K842166 | 000 |
| B15027600 | K842166 | 000 |