The following data is part of a premarket notification filed by Pascall Saringia Medical Corp. with the FDA for Shielded Piggyback Iv Needle.
| Device ID | K900353 |
| 510k Number | K900353 |
| Device Name: | SHIELDED PIGGYBACK IV NEEDLE |
| Classification | Set, Administration, Intravascular |
| Applicant | PASCALL SARINGIA MEDICAL CORP. SUITE 416, CAPE ROYAL BUILDING 1980 N. ATLANTIC AVENUE Cocoa Beach, FL 32931 |
| Contact | Kornberg, Md |
| Correspondent | Kornberg, Md PASCALL SARINGIA MEDICAL CORP. SUITE 416, CAPE ROYAL BUILDING 1980 N. ATLANTIC AVENUE Cocoa Beach, FL 32931 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-25 |
| Decision Date | 1990-06-22 |