The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Obstetrical Vacuum Cup.
| Device ID | K911326 |
| 510k Number | K911326 |
| Device Name: | OBSTETRICAL VACUUM CUP |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | GESCO INTL., INC. 5714 EPSILON DR. San Antonio, TX 78249 |
| Contact | Clyde N Baker |
| Correspondent | Clyde N Baker GESCO INTL., INC. 5714 EPSILON DR. San Antonio, TX 78249 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-26 |
| Decision Date | 1991-08-14 |