The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Sechrist Disposable Infant Breathing Circuit.
| Device ID | K895853 |
| 510k Number | K895853 |
| Device Name: | SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | SECHRIST INDUSTRIES, INC. 2820 GRETTA LN. Anaheim, CA 92806 |
| Contact | Sandra L Davis |
| Correspondent | Sandra L Davis SECHRIST INDUSTRIES, INC. 2820 GRETTA LN. Anaheim, CA 92806 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-03 |
| Decision Date | 1989-12-22 |