The following data is part of a premarket notification filed by Rennels Medical Corp. with the FDA for Renmed Contami-shield Breathing Circuit Sleeve, Model 9999/01.
| Device ID | K013200 |
| 510k Number | K013200 |
| Device Name: | RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | RENNELS MEDICAL CORP. PO BOX 3626 Morganton, NC 28680 -3626 |
| Contact | David Lee |
| Correspondent | David Lee RENNELS MEDICAL CORP. PO BOX 3626 Morganton, NC 28680 -3626 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-25 |
| Decision Date | 2001-12-14 |
| Summary: | summary |