The following data is part of a premarket notification filed by Charles Polo & Co., Inc. with the FDA for Insufflation Tubing Sterile And Non-sterile.
| Device ID | K935639 |
| 510k Number | K935639 |
| Device Name: | INSUFFLATION TUBING STERILE AND NON-STERILE |
| Classification | Insufflator, Laparoscopic |
| Applicant | CHARLES POLO & CO., INC. 12714 HOOVER ST. Garden Grove, CA 92841 |
| Contact | Charles Spina |
| Correspondent | Charles Spina CHARLES POLO & CO., INC. 12714 HOOVER ST. Garden Grove, CA 92841 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-23 |
| Decision Date | 1994-03-17 |