The following data is part of a premarket notification filed by Churchill Medical Systems, Inc. with the FDA for Primary Solution Set With Universal Spike, Injection Site And Male Luer Lock.
| Device ID | K011336 |
| 510k Number | K011336 |
| Device Name: | PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK |
| Classification | Set, Administration, Intravascular |
| Applicant | CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. Dover, NH 03820 |
| Contact | Keith Paulch |
| Correspondent | Keith Paulch CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. Dover, NH 03820 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-02 |
| Decision Date | 2001-06-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884003582 | K011336 | 000 |
| 30849884000369 | K011336 | 000 |
| 30849884000352 | K011336 | 000 |
| 30849884000345 | K011336 | 000 |
| 30849884004022 | K011336 | 000 |
| 30849884004015 | K011336 | 000 |
| 30849884003995 | K011336 | 000 |
| 30849884003988 | K011336 | 000 |
| 30849884003773 | K011336 | 000 |
| 38498840011639 | K011336 | 000 |
| 38498840006536 | K011336 | 000 |
| 30849884003964 | K011336 | 000 |
| 30849884000383 | K011336 | 000 |
| 30849884000390 | K011336 | 000 |
| 30849884000413 | K011336 | 000 |
| 30849884002622 | K011336 | 000 |
| 30849884000574 | K011336 | 000 |
| 30849884000437 | K011336 | 000 |
| 30849884000420 | K011336 | 000 |
| 30849884000406 | K011336 | 000 |
| 30849884000291 | K011336 | 000 |
| 30849884000284 | K011336 | 000 |
| 30849884000581 | K011336 | 000 |
| 30849884000307 | K011336 | 000 |
| 30849884000277 | K011336 | 000 |
| 30849884001861 | K011336 | 000 |
| 30849884003452 | K011336 | 000 |