The following data is part of a premarket notification filed by Bryan Corp. with the FDA for Microprocessed Controlled Laparoflator.
| Device ID | K913242 |
| 510k Number | K913242 |
| Device Name: | MICROPROCESSED CONTROLLED LAPAROFLATOR |
| Classification | Insufflator, Laparoscopic |
| Applicant | BRYAN CORP. FOUR PLYMPTON ST. Woburn, MA 01801 |
| Contact | Frank M Abrano |
| Correspondent | Frank M Abrano BRYAN CORP. FOUR PLYMPTON ST. Woburn, MA 01801 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-22 |
| Decision Date | 1992-09-25 |