The following data is part of a premarket notification filed by Intl. Medical Devices Ltd. with the FDA for Wisss Pediatric Trach- Tube W/obturator.
| Device ID | K843785 |
| 510k Number | K843785 |
| Device Name: | WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | INTL. MEDICAL DEVICES LTD. 19205 PARTHENIA SUITE J Northridge , CA 91324 - |
| Contact | Marcia Weiss |
| Correspondent | Marcia Weiss INTL. MEDICAL DEVICES LTD. 19205 PARTHENIA SUITE J Northridge , CA 91324 - |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-27 |
| Decision Date | 1984-10-23 |