The following data is part of a premarket notification filed by Fine Surgical Instrument Corp. with the FDA for Fine Surgical Circumcision Clamp.
| Device ID | K040052 |
| 510k Number | K040052 |
| Device Name: | FINE SURGICAL CIRCUMCISION CLAMP |
| Classification | Clamp, Circumcision |
| Applicant | FINE SURGICAL INSTRUMENT CORP. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula FINE SURGICAL INSTRUMENT CORP. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Product Code | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-12 |
| Decision Date | 2004-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0995403960 | K040052 | 000 |
| 10884527023127 | K040052 | 000 |
| 10884527023110 | K040052 | 000 |
| 10884527023103 | K040052 | 000 |
| 10884527023097 | K040052 | 000 |
| 10884527023073 | K040052 | 000 |
| 10884527023059 | K040052 | 000 |
| 10884527023042 | K040052 | 000 |
| 10884527007059 | K040052 | 000 |
| 10884527007042 | K040052 | 000 |
| 10884527007035 | K040052 | 000 |
| 10884527007028 | K040052 | 000 |
| 10884527007011 | K040052 | 000 |
| 10884527006991 | K040052 | 000 |
| 10884527006984 | K040052 | 000 |
| 10884521157163 | K040052 | 000 |
| 10889942321148 | K040052 | 000 |
| 10889942321131 | K040052 | 000 |
| 10884527023141 | K040052 | 000 |
| 20884527007001 | K040052 | 000 |
| B099540394B0 | K040052 | 000 |
| B0995403940 | K040052 | 000 |
| B099540392B0 | K040052 | 000 |
| B0995403920 | K040052 | 000 |
| B099540390B0 | K040052 | 000 |
| B0995403900 | K040052 | 000 |
| B099540388B0 | K040052 | 000 |
| B0995403800 | K040052 | 000 |
| B0995403740 | K040052 | 000 |
| 00869401000237 | K040052 | 000 |
| 00869401000220 | K040052 | 000 |
| 00869401000213 | K040052 | 000 |
| 00869401000206 | K040052 | 000 |
| B0995404020 | K040052 | 000 |
| B0995404010 | K040052 | 000 |
| B099540396B0 | K040052 | 000 |
| B0995403890 | K040052 | 000 |
| 10080196301898 | K040052 | 000 |