The following data is part of a premarket notification filed by Central Georgia Ancillary Health Systems with the FDA for Sterile Surgical Gown Pack.
| Device ID | K911131 |
| 510k Number | K911131 |
| Device Name: | STERILE SURGICAL GOWN PACK |
| Classification | Drape, Surgical |
| Applicant | CENTRAL GEORGIA ANCILLARY HEALTH SYSTEMS 4269 INTERSTATE PKWY. Macon, GA 31204 |
| Contact | Jack Herndon |
| Correspondent | Jack 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 | 1991-03-14 |
| Decision Date | 1991-09-16 |