The following data is part of a premarket notification filed by Carie Med-tech Services, Inc. with the FDA for Carie Med-tech Model 210 Rainout Drainage System.
Device ID | K932722 |
510k Number | K932722 |
Device Name: | CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM |
Classification | Drain, Tee (water Trap) |
Applicant | CARIE MED-TECH SERVICES, INC. P.O. BOX 449 Olney, IL 62450 |
Contact | David Carie |
Correspondent | David Carie CARIE MED-TECH SERVICES, INC. P.O. BOX 449 Olney, IL 62450 |
Product Code | BYH |
CFR Regulation Number | 868.5995 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-04 |
Decision Date | 1993-08-06 |