The following data is part of a premarket notification filed by Central Georgia Ancillary Health Systems with the FDA for Surgical Gown Pack.
| Device ID | K923798 |
| 510k Number | K923798 |
| Device Name: | SURGICAL GOWN PACK |
| Classification | Drape, Surgical |
| Applicant | CENTRAL GEORGIA ANCILLARY HEALTH SYSTEMS 4269 INTERSTATE PKWY. Macon, GA 31204 |
| Contact | Jack D Herndon |
| Correspondent | Jack D Herndon CENTRAL GEORGIA ANCILLARY HEALTH SYSTEMS 4269 INTERSTATE PKWY. Macon, GA 31204 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-20 |
| Decision Date | 1993-01-27 |