The following data is part of a premarket notification filed by Kit Pak, Inc. with the FDA for Kit Pak Suction Catheter Kit.
| Device ID | K885131 |
| 510k Number | K885131 |
| Device Name: | KIT PAK SUCTION CATHETER KIT |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | KIT PAK, INC. 825 CHASE AVE. Elk Grove Village, IL 60007 |
| Contact | James S Sanders |
| Correspondent | James S Sanders KIT PAK, INC. 825 CHASE AVE. Elk Grove Village, IL 60007 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-12 |
| Decision Date | 1989-01-09 |