The following data is part of a premarket notification filed by Std Mfg., Inc. with the FDA for Std Irrigation Pump.
| Device ID | K930427 |
| 510k Number | K930427 |
| Device Name: | STD IRRIGATION PUMP |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | STD MFG., INC. 1063 TURNPIKE ST. P.O. BOX 420 Stoughton, MA 02072 |
| Contact | Steven J Tallarida |
| Correspondent | Steven J Tallarida STD MFG., INC. 1063 TURNPIKE ST. P.O. BOX 420 Stoughton, MA 02072 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-26 |
| Decision Date | 1993-06-01 |