The following data is part of a premarket notification filed by Churchill Medical Systems, Inc. with the FDA for 30 Iv Extension Set W/two Male Luer Locks.
Device ID | K882503 |
510k Number | K882503 |
Device Name: | 30 IV EXTENSION SET W/TWO MALE LUER LOCKS |
Classification | Set, Administration, Intravascular |
Applicant | CHURCHILL MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham, PA 19044 |
Contact | Joel A Marcus |
Correspondent | Joel A Marcus CHURCHILL MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham, PA 19044 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-17 |
Decision Date | 1988-08-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30849884002578 | K882503 | 000 |
30849884001366 | K882503 | 000 |
30849884004435 | K882503 | 000 |
30849884004428 | K882503 | 000 |
30849884001380 | K882503 | 000 |
30849884001335 | K882503 | 000 |
30849884003025 | K882503 | 000 |
30849884002844 | K882503 | 000 |
30849884003261 | K882503 | 000 |
30849884003254 | K882503 | 000 |
30849884005111 | K882503 | 000 |
30849884005647 | K882503 | 000 |
30849884003377 | K882503 | 000 |
30849884002813 | K882503 | 000 |
30849884005968 | K882503 | 000 |
30849884005951 | K882503 | 000 |
30849884005944 | K882503 | 000 |
30849884000475 | K882503 | 000 |
30849884000482 | K882503 | 000 |
30849884001854 | K882503 | 000 |
30849884002059 | K882503 | 000 |
30849884003322 | K882503 | 000 |
30849884003315 | K882503 | 000 |
30849884003308 | K882503 | 000 |
30849884002851 | K882503 | 000 |
30849884002615 | K882503 | 000 |
30849884002134 | K882503 | 000 |
30849884001694 | K882503 | 000 |
30849884001687 | K882503 | 000 |
30849884001458 | K882503 | 000 |
30849884001427 | K882503 | 000 |
30849884001281 | K882503 | 000 |
30849884000543 | K882503 | 000 |
30849884000529 | K882503 | 000 |
30849884000499 | K882503 | 000 |
30849884001618 | K882503 | 000 |
30849884005937 | K882503 | 000 |