The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Sharpsaway Ii Locking Disposable Cup.
| Device ID | K041153 |
| 510k Number | K041153 |
| Device Name: | SHARPSAWAY II LOCKING DISPOSABLE CUP |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Elizabeth Price |
| Correspondent | Elizabeth Price ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-03 |
| Decision Date | 2004-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801902025702 | K041153 | 000 |
| 20801902113003 | K041153 | 000 |
| 20801902143574 | K041153 | 000 |
| 20801902158851 | K041153 | 000 |
| 30801902131110 | K041153 | 000 |