The following data is part of a premarket notification filed by Procter & Gamble Mfg. Co. with the FDA for Laparoscopy Drape, Boundary.
| Device ID | K772301 |
| 510k Number | K772301 |
| Device Name: | LAPAROSCOPY DRAPE, BOUNDARY |
| Classification | Cutter, Surgical |
| Applicant | PROCTER & GAMBLE MFG. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FZT |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-14 |
| Decision Date | 1977-12-20 |