The following data is part of a premarket notification filed by Kappler, Inc. with the FDA for Kappler Pro/vent Procedure Gown.
| Device ID | K932694 |
| 510k Number | K932694 |
| Device Name: | KAPPLER PRO/VENT PROCEDURE GOWN |
| Classification | Gown, Surgical |
| Applicant | KAPPLER, INC. P.O. BOX 218 5000 GRIMES DRIVE Guntersville, AL 35976 |
| Contact | Philip C Mann |
| Correspondent | Philip C Mann KAPPLER, INC. P.O. BOX 218 5000 GRIMES DRIVE Guntersville, AL 35976 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-03 |
| Decision Date | 1994-03-29 |