The following data is part of a premarket notification filed by Innovatec Medical Corp. with the FDA for Inflatable Retention Cuff Speculum.
| Device ID | K941391 |
| 510k Number | K941391 |
| Device Name: | INFLATABLE RETENTION CUFF SPECULUM |
| Classification | Catheter, Rectal |
| Applicant | INNOVATEC MEDICAL CORP. 4809 RIVERVIEW WAY Duluth, GA 30097 |
| Contact | Roy Abell |
| Correspondent | Roy Abell INNOVATEC MEDICAL CORP. 4809 RIVERVIEW WAY Duluth, GA 30097 |
| Product Code | GBT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-22 |
| Decision Date | 1994-10-20 |