The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Civ-flex Holster Cover, Model Sterile, Latex-free.
| Device ID | K002546 |
| 510k Number | K002546 |
| Device Name: | CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE |
| Classification | Instrument, Biopsy |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 102 FIRST ST. SOUTH Kalona, IA 52247 |
| Contact | J. William Jones |
| Correspondent | J. William Jones CIVCO MEDICAL INSTRUMENTS CO., INC. 102 FIRST ST. SOUTH Kalona, IA 52247 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-17 |
| Decision Date | 2000-10-31 |
| Summary: | summary |