The following data is part of a premarket notification filed by Innovative Endoscopy Components, Llc. with the FDA for Baho Autoclavable Cystoscope.
| Device ID | K992983 |
| 510k Number | K992983 |
| Device Name: | BAHO AUTOCLAVABLE CYSTOSCOPE |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | INNOVATIVE ENDOSCOPY COMPONENTS, LLC. 1112 WESTON RD., SUITE 227 Ft. Lauderdale, FL 33326 |
| Contact | Gerald Goigitzer |
| Correspondent | Gerald Goigitzer INNOVATIVE ENDOSCOPY COMPONENTS, LLC. 1112 WESTON RD., SUITE 227 Ft. Lauderdale, FL 33326 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-03 |
| Decision Date | 1999-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B192300515000 | K992983 | 000 |
| B192300421000 | K992983 | 000 |
| B192300348000 | K992983 | 000 |
| B192300346000 | K992983 | 000 |
| B192300057000 | K992983 | 000 |
| B192300055000 | K992983 | 000 |
| B192300054000 | K992983 | 000 |