The following data is part of a premarket notification filed by Norfolk Medical Products, Inc. with the FDA for Norfolk Medical Butterfly Infusion Set.
| Device ID | K870188 |
| 510k Number | K870188 |
| Device Name: | NORFOLK MEDICAL BUTTERFLY INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | NORFOLK MEDICAL PRODUCTS, INC. 7307 N. RIDGEWAY Skokie, IL 60076 |
| Contact | Michael J Dalton |
| Correspondent | Michael J Dalton NORFOLK MEDICAL PRODUCTS, INC. 7307 N. RIDGEWAY Skokie, IL 60076 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-16 |
| Decision Date | 1987-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M991CVS615102 | K870188 | 000 |
| M991CVS612102 | K870188 | 000 |
| M991CVS611102 | K870188 | 000 |