The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Blunt Needle.
| Device ID | K981386 |
| 510k Number | K981386 |
| Device Name: | MANAN BLUNT NEEDLE |
| Classification | Set, Administration, Intravascular |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Contact | Michael Plishka |
| Correspondent | Michael Plishka MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-16 |
| Decision Date | 1998-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40195327155569 | K981386 | 000 |
| 40198459043872 | K981386 | 000 |