The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Civco Probe Boot/cord Cover.
| Device ID | K943393 |
| 510k Number | K943393 |
| Device Name: | CIVCO PROBE BOOT/CORD COVER |
| Classification | Drape, Surgical |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. MEDICAL PKWY. 102 HIGHWAY 1 SOUTH Kalona, IA 52247 |
| Contact | J. William Jones |
| Correspondent | J. William Jones CIVCO MEDICAL INSTRUMENTS CO., INC. MEDICAL PKWY. 102 HIGHWAY 1 SOUTH Kalona, IA 52247 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-14 |
| Decision Date | 1995-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841436101417 | K943393 | 000 |
| 00841436101400 | K943393 | 000 |
| 00841436106009 | K943393 | 000 |