The following data is part of a premarket notification filed by Thayer Medical Corp. with the FDA for Thayer Semi-rigid Condensate Collection System.
| Device ID | K897057 |
| 510k Number | K897057 |
| Device Name: | THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM |
| Classification | Drain, Tee (water Trap) |
| Applicant | THAYER MEDICAL CORP. 8141 E. MCLAREN P.O. BOX 57907 Tucson, AZ 85715 |
| Contact | David Sladek |
| Correspondent | David Sladek THAYER MEDICAL CORP. 8141 E. MCLAREN P.O. BOX 57907 Tucson, AZ 85715 |
| Product Code | BYH |
| CFR Regulation Number | 868.5995 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-18 |
| Decision Date | 1990-03-16 |