The following data is part of a premarket notification filed by Churchill Medical Systems, Inc. with the FDA for Wing Safe Infusion Set 20 Ga, Shs2000 Series; Wing Safe Infusion Set 19 Ga, Shs1900 Series; Wing Safe Infusion Set 22 Ga.
| Device ID | K020544 |
| 510k Number | K020544 |
| Device Name: | WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA |
| Classification | Set, Administration, Intravascular |
| Applicant | CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. Dover, NH 03820 |
| Contact | Keith Paluch |
| Correspondent | Keith Paluch CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. Dover, NH 03820 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-15 |
| Decision Date | 2002-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38498840010540 | K020544 | 000 |
| 58498840007162 | K020544 | 000 |
| 38498840006604 | K020544 | 000 |
| 30849884004145 | K020544 | 000 |
| 38498840010731 | K020544 | 000 |
| 38498840010380 | K020544 | 000 |
| 38498840010373 | K020544 | 000 |
| 38498840010267 | K020544 | 000 |
| 30849884006415 | K020544 | 000 |
| 30849884006408 | K020544 | 000 |
| 30849884006460 | K020544 | 000 |
| 30849884006453 | K020544 | 000 |
| 30849884006439 | K020544 | 000 |
| 38498840007175 | K020544 | 000 |
| 38498840007182 | K020544 | 000 |
| 38498840007199 | K020544 | 000 |
| 38498840010533 | K020544 | 000 |
| 38498840010526 | K020544 | 000 |
| 38498840010519 | K020544 | 000 |
| 58498840008770 | K020544 | 000 |
| 58498840007292 | K020544 | 000 |
| 38498840007281 | K020544 | 000 |
| 58498840007261 | K020544 | 000 |
| 38498840007250 | K020544 | 000 |
| 58498840007247 | K020544 | 000 |
| 58498840007223 | K020544 | 000 |
| 38498840007212 | K020544 | 000 |
| 58498840007209 | K020544 | 000 |
| 30849884006422 | K020544 | 000 |