The following data is part of a premarket notification filed by Microptix Int'l, Llc. with the FDA for Baho Autoclavable Laparoscope.
| Device ID | K982276 |
| 510k Number | K982276 |
| Device Name: | BAHO AUTOCLAVABLE LAPAROSCOPE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | MICROPTIX INT'L, LLC. 310 MAIN ST., SUITE LL-D East Haven, CT 06512 |
| Contact | George N Hallack |
| Correspondent | George N Hallack MICROPTIX INT'L, LLC. 310 MAIN ST., SUITE LL-D East Haven, CT 06512 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-29 |
| Decision Date | 1999-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B192300495000 | K982276 | 000 |
| B192300494000 | K982276 | 000 |
| B192300428000 | K982276 | 000 |
| B192300427000 | K982276 | 000 |
| B192300401000 | K982276 | 000 |
| B192300083000 | K982276 | 000 |